children's delsym ®

SPL v5

SPL

SPL Set ID 9aca1a68-893c-4770-8a48-d5d678058253

Route

oral

Published

Effective Date 2022-01-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (5 mg) guaifenesin (100 mg) acetaminophen (325 mg) diphenhydramine (12.5 mg) phenylephrine

Inactive Ingredients

anhydrous citric acid edetate disodium fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate sorbitol sucralose trisodium citrate dihydrate xanthan gum fd&c blue no. 1

Identifiers & Packaging

Pill Appearance

Color: red Color: blue

Marketing Status

otc monograph drug active Since 2017-07-01

Description

COUGH+ CHEST CONGESTION DM - AGES 4+ Drug Facts

Medication Information

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep

Directions

do not give more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

Age (year)	Dose (mL)
children 6 to under 12 years of age	5 mL – 10 mL every 4 hours
children 4 to under 6 years of age	2.5 mL – 5 mL every 4 hours
children under 4 years of age	do not use

Other Information

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Description

COUGH+ CHEST CONGESTION DM - AGES 4+ Drug Facts

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Section 42229-5

COUGH+ CHEST CONGESTION DM - AGES 4+

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product do not use more than directed

Section 50570-1

Do not usein a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Section 55105-1

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
to make a child sleepy
with any other product containing diphenhydramine, even one used on the skin
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

When Using This Product

do not use more than directed (see Overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Principal Display Panel Kit Carton

NDC 63824-218-22

DAY

NIGHT

COMBO

PACK

Children's

Delsym ^®

COUGH+ ^®

Chest Congestion

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Relieves Cough
Relieves Chest

Congestion
Thins &

Loosens

Mucus

Cherry Flavor

For Ages

4

years+

COUGH+ ^®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough
Relieves

Stuffy Nose
Relieves

Sore Throat
Reduces Fever

Berry Flavor

For Ages

6

years+

TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)

Ask A Doctor Before Use If the Child Has

persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep

Directions

do not give more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

Age (year)	Dose (mL)
children 6 to under 12 years of age	5 mL – 10 mL every 4 hours
children 4 to under 6 years of age	2.5 mL – 5 mL every 4 hours
children under 4 years of age	do not use

Other Information (Other information)

each 5 mL contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Section 42229-5 (42229-5)

COUGH+ CHEST CONGESTION DM - AGES 4+

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
to make a child sleepy
with any other product containing diphenhydramine, even one used on the skin
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Overdose Warning (Overdose warning)

Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

When Using This Product (When using this product)

do not use more than directed (see Overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

NDC 63824-218-22

DAY

NIGHT

COMBO

PACK

Children's

Delsym ^®

COUGH+ ^®

Chest Congestion

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Relieves Cough
Relieves Chest

Congestion
Thins &

Loosens

Mucus

Cherry Flavor

For Ages

4

years+

COUGH+ ^®Cold

Night Time

Acetaminophen (Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough
Relieves

Stuffy Nose
Relieves

Sore Throat
Reduces Fever

Berry Flavor

For Ages

6

years+

TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": 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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep", "42229-5": "COUGH+ CHEST CONGESTION DM - AGES 4+ Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed", "50570-1": "Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.", "55105-1": "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant", "Directions": "do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age (year) Dose (mL) children 6 to under 12 years of age 5 mL – 10 mL every 4 hours children 4 to under 6 years of age 2.5 mL – 5 mL every 4 hours children under 4 years of age do not use", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.", "Questions?": "1-866-682-4639 You may also report side effects to this phone number.", "Allergy alert": "Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen", "Overdose warning": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Other information": "each 5 mL contains: sodium 3 mg store between 20-25°C (68-77°F) do not refrigerate", "Sore throat warning": "If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Inactive ingredients": "anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum", "When using this product": "do not use more than directed (see Overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.", "PRINCIPAL DISPLAY PANEL - Kit Carton": "NDC 63824-218-22 DAY NIGHT COMBO PACK Children's Delsym ® COUGH+ ® Chest Congestion DM Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Relieves Cough Relieves Chest Congestion Thins & Loosens Mucus Cherry Flavor For Ages 4 years+ COUGH+ ® Cold Night Time Acetaminophen (Pain Reliever/Fever Reducer) Diphenhydramine HCl (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Cough Relieves Stuffy Nose Relieves Sore Throat Reduces Fever Berry Flavor For Ages 6 years+ TWO - 4 fl oz (118 mL) bottles TOTAL - 8 fl oz (236 mL)", "Ask a doctor before use if the child has": "persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if the child is": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.625742 · Updated: 2026-03-14T23:06:11.878508