Dimetapp ® - DailyMed Details

Dimetapp ®

SPL v2

SPL

SPL Set ID 178fe95b-e1ed-43b2-e063-6294a90a7a78

Route

ORAL

Published

Effective Date 2024-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (320 mg) Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- runny nose
- sneezing
- temporarily alleviates the intensity of coughing
temporarily reduces fever

Section 42229-5

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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each 10 mL)	Purposes
Acetaminophen, 320 mg	Pain reliever/fever reducer
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant

Directions

do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosage cup provided
keep dosage cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours do not take more than 6 doses in any 24-hour period
children 6 to under 12 years	10 mL every 4 hours do not give more than 5 doses in any 24-hour period
children under 6 years	do not use

Do Not Use

to sedate a child or to make a child sleepy
in a child under 6 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product.

Other Information

each 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F)
read and keep carton

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, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

When Using This Product

do not use more than directed
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If

pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Ask A Doctor Before Use If User Has

liver disease
trouble urinating due to an enlarged prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 118 Ml Bottle Carton

NEW FORMULA

CHILDREN'S

Dimetapp ^®

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHARMACIST

RECOMMENDED

Multi-

Symptom

Cold & Flu

Relieves + comforts:

Fever
Head & body aches
Cough
Runny nose
Sneezing
Sore throat

6+

YRS

4 FL OZ

(118 mL)

Red Grape Flavor • Alcohol Free

Ask A Doctor Or Pharmacist Before Use If User Is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- runny nose
- sneezing
- temporarily alleviates the intensity of coughing
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each 10 mL)	Purposes
Acetaminophen, 320 mg	Pain reliever/fever reducer
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant

Directions

do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosage cup provided
keep dosage cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours do not take more than 6 doses in any 24-hour period
children 6 to under 12 years	10 mL every 4 hours do not give more than 5 doses in any 24-hour period
children under 6 years	do not use

Do Not Use (Do not use)

to sedate a child or to make a child sleepy
in a child under 6 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product.

Other Information (Other information)

each 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F)
read and keep carton

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.

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

When Using This Product (When using this product)

do not use more than directed
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

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

pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Ask A Doctor Before Use If User Has (Ask a doctor before use if user has)

liver disease
trouble urinating due to an enlarged prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NEW FORMULA

CHILDREN'S

Dimetapp ^®

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHARMACIST

RECOMMENDED

Multi-

Symptom

Cold & Flu

Relieves + comforts:

Fever
Head & body aches
Cough
Runny nose
Sneezing
Sore throat

6+

YRS

4 FL OZ

(118 mL)

Red Grape Flavor • Alcohol Free

Ask A Doctor Or Pharmacist Before Use If User Is (Ask a doctor or pharmacist before use if user is)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"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 RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "320", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat cough runny nose sneezing temporarily alleviates the intensity of coughing temporarily reduces fever", "42229-5": "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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant", "Directions": "do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours do not take more than 6 doses in any 24-hour period children 6 to under 12 years 10 mL every 4 hours do not give more than 5 doses in any 24-hour period children under 6 years do not use", "Do not use": "to sedate a child or to make a child sleepy in a child under 6 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product.", "Other information": "each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) read and keep carton", "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, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Questions or comments?": "Call 1-888-594-0828 weekdays 9 AM to 5 PM EST", "When using this product": "do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if": "pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.", "Ask a doctor before use if user has": "liver disease trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton": "NEW FORMULA CHILDREN'S Dimetapp ® ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHARMACIST RECOMMENDED Multi- Symptom Cold & Flu Relieves + comforts: Fever Head & body aches Cough Runny nose Sneezing Sore throat 6+ YRS 4 FL OZ (118 mL) Red Grape Flavor • Alcohol Free", "Ask a doctor or pharmacist before use if user is": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.789494 · Updated: 2026-03-14T23:13:07.898715