Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 1598e6f8-08ee-4216-a5ab-76cad37b09a7

Route

ORAL

Published

Effective Date 2023-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Cellulose, Microcrystalline Anhydrous Citric Acid Glycerin Water D&c Red No. 33 Sodium Benzoate Sorbitol Xanthan Gum Sucrose Carboxymethylcellulose Sodium Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-05-31

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCI 2.5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCI 2.5 mg

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- stuffy nose
temporarily reduces fever

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

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 contaning acetaminophen

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.

Directions

this product does not contain directions or complete warnings for adult use.
mL =milliliter
shake well before using
measure only with dosing cup provided
do not use with any other dosing device
keep dosing cup with product
do not give more than 5 times in 24 hours
if needed, repeat dose every 4 hours while symptoms last
find the right dose on chart below. If possible, use weight to dose: otherwise us

Weight (lb)	Age (yr)	Dose ( mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Do Not Use

to make a child sleepy
with any other drug containing acetaminophen (Prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Package Label

DOLLAR GENERAL HEALTH Children's Plus Flu

Other Information

store at 20-25ºC (68-77F) .Do not refrigerate

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum

Questions Or Comments?

Call 1-888-309-9030

Principal Display Panel

For ages 6 to 11 years

Children's

Plus Flu

Acetaminophen / Pain reliever

Chlorpheniramine maleate

Dextromethorphan HBr

Phenylephrine HCI

Oral Suspension

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Relieves coughs, runny nose, sneezing, fever, sore throat, stuffy nose

Grape Flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072

When Using This Product

do not exceed recommended dose ( 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

new symptoms occur
redness or swelling is present
pain, nasal congestion or cough gets worse or last more than 5 days
fever gets worse or last more than 3 days
nervousness, dizziness or sleeplessness occurs
cough comes back or occurs with rash or headache that lasts,

These could be signs of a serious condition.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 5 Ml)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCI 2.5 mg

Ask A Doctor Before Use If your Child Has

liver disease
glaucoma
thyroid disease
diabetes
heart disease
high blood pressure
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

Ask A Doctor Or Pharmacist Before Use If the Child Is Taking

sedatives or tranquilizers
the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- stuffy nose
temporarily reduces fever

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

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 contaning acetaminophen

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.

Directions

this product does not contain directions or complete warnings for adult use.
mL =milliliter
shake well before using
measure only with dosing cup provided
do not use with any other dosing device
keep dosing cup with product
do not give more than 5 times in 24 hours
if needed, repeat dose every 4 hours while symptoms last
find the right dose on chart below. If possible, use weight to dose: otherwise us

Weight (lb)	Age (yr)	Dose ( mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Do Not Use (Do not use)

to make a child sleepy
with any other drug containing acetaminophen (Prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Package Label

DOLLAR GENERAL HEALTH Children's Plus Flu

Other Information

store at 20-25ºC (68-77F) .Do not refrigerate

Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-888-309-9030

Principal Display Panel

For ages 6 to 11 years

Children's

Plus Flu

Acetaminophen / Pain reliever

Chlorpheniramine maleate

Dextromethorphan HBr

Phenylephrine HCI

Oral Suspension

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Relieves coughs, runny nose, sneezing, fever, sore throat, stuffy nose

Grape Flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072

When Using This Product (When using this product)

do not exceed recommended dose ( 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)

new symptoms occur
redness or swelling is present
pain, nasal congestion or cough gets worse or last more than 5 days
fever gets worse or last more than 3 days
nervousness, dizziness or sleeplessness occurs
cough comes back or occurs with rash or headache that lasts,

These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCI 2.5 mg

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

liver disease
glaucoma
thyroid disease
diabetes
heart disease
high blood pressure
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with asthma

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

sedatives or tranquilizers
the blood thinning drug warfarin

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "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": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache stuffy nose temporarily reduces fever", "Purposes": "Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant", "Warnings": "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 contaning acetaminophen 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.", "Directions": "this product does not contain directions or complete warnings for adult use. mL =milliliter shake well before using measure only with dosing cup provided do not use with any other dosing device keep dosing cup with product do not give more than 5 times in 24 hours if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose: otherwise us Weight (lb) Age (yr) Dose ( mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use", "Do not use": "to make a child sleepy with any other drug containing acetaminophen (Prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.", "Package Label": "DOLLAR GENERAL HEALTH Children's Plus Flu", "Other Information": "store at 20-25ºC (68-77F) .Do not refrigerate", "Inactive ingredients": "carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose xanthan gum", "Questions or comments?": "Call 1-888-309-9030", "Principal Display Panel": "For ages 6 to 11 years Children's Plus Flu Acetaminophen / Pain reliever Chlorpheniramine maleate Dextromethorphan HBr Phenylephrine HCI Oral Suspension Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant Relieves coughs, runny nose, sneezing, fever, sore throat, stuffy nose Grape Flavor FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION . DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072", "When using this product": "do not exceed recommended dose ( 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": "new symptoms occur redness or swelling is present pain, nasal congestion or cough gets worse or last more than 5 days fever gets worse or last more than 3 days nervousness, dizziness or sleeplessness occurs cough comes back or occurs with rash or headache that lasts, These could be signs of a serious condition.", "Keep out of reach of children.": "Overdose warning: Taking more than the recommended dose (overdose) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Active ingredients (in each 5 mL)": "Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCI 2.5 mg", "Ask a doctor before use if your child has": "liver disease glaucoma thyroid disease diabetes heart disease high blood pressure a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma", "Ask a doctor or pharmacist before use if the child is taking": "sedatives or tranquilizers the blood thinning drug warfarin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:26.879458 · Updated: 2026-03-14T23:01:59.101977