Dimetapp Cough And Allergy Chewable

SPL v2

SPL

SPL Set ID 15b0f5ff-202a-d19f-e063-6394a90af2b8

Route

ORAL

Published

Effective Date 2024-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Fd&c Blue No. 1 Aluminum Lake Modified Corn Starch (1-octenyl Succinic Anhydride) Sucralose Sucrose D&c Red No. 30 Magnesium Stearate D&c Red No. 27 Aluminum Lake Dextrates Ethylcellulose, Unspecified Hydroxypropyl Cellulose, Unspecified Mannitol Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: DT Shape: round Color: purple Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-15

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Description

Drug Facts

Uses

temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily alleviates the intensity of coughing

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.

Section 55105-1

Active ingredients (in each chewable tablet)	Purposes
Diphenhydramine HCl 12.5 mg	Antihistamine/Cough suppresant

Section 55106-9

Diphenhydramine HCl 12.5 mg

Directions

chew or crush tablets completely before swallowing, do not swallow tablets whole
do not take more than 6 doses in 24 hours

age	dose
adults and children 12 years and over	take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
children 6 to under 12 years	take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
children under 6 years	do not use

Do Not Use

to sedate a child or make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information

store at 20-25°C (68-77°F)
avoid high humidity

Inactive Ingredients

D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose

Questions Or Comments?

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

When Using This Product

may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a vehicle or operating machinery
excitability may occur, expecially in children

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Before Use If You Have

glaucoma
trouble urinating due to enlarged prostate gland
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 24 Ct Carton

CHILDREN'S

Dimetapp

DIPHENHYDRAMINE HCl, 12.5 mg

(Antihistamine/Cough Suppressant)

GREAT CHEWABLE TASTE

Cough & Allergy

Relieves + comforts:

Cough
Itchy throat
Sneezing
Runny nose

6+ years

24 CHEWABLE TABLETS

Grape-Flavored

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves:
- cough
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily alleviates the intensity of coughing

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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 55105-1 (55105-1)

Active ingredients (in each chewable tablet)	Purposes
Diphenhydramine HCl 12.5 mg	Antihistamine/Cough suppresant

Section 55106-9 (55106-9)

Diphenhydramine HCl 12.5 mg

Directions

chew or crush tablets completely before swallowing, do not swallow tablets whole
do not take more than 6 doses in 24 hours

age	dose
adults and children 12 years and over	take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours
children 6 to under 12 years	take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours
children under 6 years	do not use

Do Not Use (Do not use)

to sedate a child or make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

store at 20-25°C (68-77°F)
avoid high humidity

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a vehicle or operating machinery
excitability may occur, expecially in children

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

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

glaucoma
trouble urinating due to enlarged prostate gland
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 24 Ct Carton (PRINCIPAL DISPLAY PANEL - 24 ct Carton)

CHILDREN'S

Dimetapp

DIPHENHYDRAMINE HCl, 12.5 mg

(Antihistamine/Cough Suppressant)

GREAT CHEWABLE TASTE

Cough & Allergy

Relieves + comforts:

Cough
Itchy throat
Sneezing
Runny nose

6+ years

24 CHEWABLE TABLETS

Grape-Flavored

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)", "unii": "461P5CJN6T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRATES", "unii": "G263MI44RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily alleviates the intensity of coughing", "34071-1": "Warnings", "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.", "55105-1": "Active ingredients (in each chewable tablet) Purposes Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppresant", "55106-9": "Diphenhydramine HCl 12.5 mg", "Directions": "chew or crush tablets completely before swallowing, do not swallow tablets whole do not take more than 6 doses in 24 hours age dose adults and children 12 years and over take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours children 6 to under 12 years take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours children under 6 years do not use", "Do not use": "to sedate a child or make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "store at 20-25°C (68-77°F) avoid high humidity", "Inactive ingredients": "D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose", "Questions or comments?": "Call 1-888-594-0828 weekdays 9 AM to 5PM EST", "When using this product": "may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a vehicle or operating machinery excitability may occur, expecially in children", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "If pregnant or breast-feeding": "ask a health professional before use.", "Ask a doctor before use if you have": "glaucoma trouble urinating due to enlarged prostate gland 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 - 24 ct Carton": "CHILDREN'S Dimetapp DIPHENHYDRAMINE HCl, 12.5 mg (Antihistamine/Cough Suppressant) GREAT CHEWABLE TASTE Cough & Allergy Relieves + comforts: Cough Itchy throat Sneezing Runny nose 6+ years 24 CHEWABLE TABLETS Grape-Flavored", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:58.051968 · Updated: 2026-03-14T23:02:46.668637