Dimetapp ®

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (6.25 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2021-09-15 Until 2026-12-31

Medication Information

Description

Drug Facts

Uses

temporarily relieves:
- nasal congestion
- runny nose
- cough
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily restores freer breathing through the nose

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 53414-9

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

Section 55105-1

Active ingredients (in each 10 mL)	Purposes
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl, 5 mg	Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
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
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Do Not Use

to sedate a child or to make a child sleepy
If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
with any other product containing diphenhydramine, even one used on skin

Other Information

each 10 mL contains: sodium 8 mg
store at 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

Call 1-888-594-0828weekdays 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

nervousness, dizziness or sleeplessness occurs
symptoms do not get better within 7 days or are accompanied by fever
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.

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
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

CHILDREN'S

Dimetapp ^®

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCl (Nasal Decongestant)

PHARMACIST

RECOMMENDED

Nighttime

Cold &

Congestion

Relieves + comforts:

Stuffy, runny nose
Itchy, watery eyes
Sneezing
Cough

6+

YRS

4 FL OZ

(118 mL)

Grape Flavor • Alcohol Free

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves:
- nasal congestion
- runny nose
- cough
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily restores freer breathing through the nose

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 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
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl, 5 mg	Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
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
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Do Not Use (Do not use)

to sedate a child or to make a child sleepy
If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

each 10 mL contains: sodium 8 mg
store at 20-25°C (68-77°F)
do not refrigerate

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

Call 1-888-594-0828weekdays 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)

nervousness, dizziness or sleeplessness occurs
symptoms do not get better within 7 days or are accompanied by fever
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.

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

heart disease
high blood pressure
thyroid disease
diabetes
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)

CHILDREN'S

Dimetapp ^®

DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

PHENYLEPHRINE HCl (Nasal Decongestant)

PHARMACIST

RECOMMENDED

Nighttime

Cold &

Congestion

Relieves + comforts:

Stuffy, runny nose
Itchy, watery eyes
Sneezing
Cough

6+

YRS

4 FL OZ

(118 mL)

Grape Flavor • Alcohol Free

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

taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves: nasal congestion runny nose cough sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 10 mL) Purposes Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant", "Directions": "do not take more than 6 doses in any 24-hour period 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 children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use", "Do not use": "to sedate a child or to make a child sleepy If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other product containing diphenhydramine, even one used on skin", "Other information": "each 10 mL contains: sodium 8 mg store at 20-25°C (68-77°F) do not refrigerate", "Inactive ingredients": "anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, 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": "nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever 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.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes 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": "CHILDREN'S Dimetapp ® DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) PHARMACIST RECOMMENDED Nighttime Cold & Congestion Relieves + comforts: Stuffy, runny nose Itchy, watery eyes Sneezing Cough 6+ YRS 4 FL OZ (118 mL) Grape Flavor • Alcohol Free", "Ask a doctor or pharmacist before use if you are": "taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information