Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3
Route
ORAL
Published
Effective Date 2024-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg) Phenylephrine (5 mg) Brompheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Fd&c Blue No. 1 Propylene Glycol Water Fd&c Red No. 40 Acesulfame Potassium Anhydrous Citric Acid Edetate Disodium Maltitol Sodium Benzoate Trisodium Citrate Dihydrate Glycerin Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-04
Description

Diphenhydramine HCI 12.5 mg Phenylephrine HCI 5 mg 

Purpose

Antihistamine Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Diphenhydramine HCI 12.5 mg Phenylephrine HCI 5 mg 

Uses

Nighttime

  • temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Daytime

  • temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis)
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Directions

Nighttime

  • do not take more than 6 doses in any 24 hours period
  • do not exceed recommended dosage
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = mililiter
Age Dose 
 adults and children 12 years and over  20 mL every 4 hours
 childen 6 to under 12 years  10 mL every 4 hours
 children under 6 years  do not use

Daytime

  • do not take more than 6 doses in any 24 hours period
  • measure only with dosing cup provided. Do not use any other dosing dosing device.
  • keep dosing cup with product
  • mL = mililiter
Age  Dose 
 adults and children12 years and over  20 mL every 4 hours
 children 6 to under 11 years  10 mL every 4 hours
 Children under 6 years  do not use


Do Not Use

Nighttime

  • 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.

Daytime

  • to sedate a child or to make sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. 
Product Label
WALGREENS Children's Cold & Congestion Relief, Children's Cold & Cough Relief
Other Information

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store at 20-25ºC (68-77ºF)
  • do not refrigerate
  • protect from light

Daytime

  • each 10 mL contains: 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Purpose for Daytime

Antihistamine

Cough suppressant

Nasal decongestant

Inactive Ingredients

Nighttime

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C Blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Daytime

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Purpose for Nighttime

Antihistamine / Cough suppressant

Nasal Decongestant

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Dimetapp® Cold & Cough & Nighttime Cold & Congestion††

Children's Cold & Congestion Relief

DIPHENHYDRAMINE HCl 12.5 mg /

ANRIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCl 5 mg /

NASAL DECONGESTANT

Nighttime

Alcohol Free

  • Relieves stuffy nose, runny nose, sneezing, itchy & watery eyes & coughing

AGES 6 YEARS & OLDER

Grape flavor

DOSING CUP INCLUDED

AGES 6 + YEARS

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

††This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Nighttime Cold & Congestion.

DAYTIME

Children's Cold & Cough Relief

BROMPHENIRAMINE MALEATE 2 mg

ANTIHISTAMINE

DEXTROMETHORPHAN HBr 10 mg /

COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg /

NASAL DECONGESTANT

Daytime

Alcohol Free

  • Relieves nasal congestion, runny nose, itchy & watery eyes, sneezing & coughing

AGES 6 YEARS & OLDER

Grape flavor

FL OZ (mL)

††This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Children's Dimetapp® Cold & Cough.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using These Products

Nighttime

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

Daytime

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedative 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

Nighttime

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with a 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

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve 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
If Pregnant Or Breast Feeding,

Nighttime

ask a health professional before use.

Daytime

ask a health professional before use

Keep Out of Reach of Children.

Nighttime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

Nighttime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that last as occurs with smoking,asthma, chronic bronchitis or emphysema

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredients for Daytime (in Each 10 Ml)

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10mg 

Phenylephrine HCl 5 mg

Active Ingredients for Nighttime (in Each 10 Ml)

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg 

Ask A Doctor Or Pharmacist Before Use If You Are

Nighttime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

Daytime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

Structured Label Content

Uses

Nighttime

  • temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Daytime

  • temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis)
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Directions

Nighttime

  • do not take more than 6 doses in any 24 hours period
  • do not exceed recommended dosage
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = mililiter
Age Dose 
 adults and children 12 years and over  20 mL every 4 hours
 childen 6 to under 12 years  10 mL every 4 hours
 children under 6 years  do not use

Daytime

  • do not take more than 6 doses in any 24 hours period
  • measure only with dosing cup provided. Do not use any other dosing dosing device.
  • keep dosing cup with product
  • mL = mililiter
Age  Dose 
 adults and children12 years and over  20 mL every 4 hours
 children 6 to under 11 years  10 mL every 4 hours
 Children under 6 years  do not use


Do Not Use (Do not use)

Nighttime

  • 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.

Daytime

  • to sedate a child or to make sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. 
Product Label
WALGREENS Children's Cold & Congestion Relief, Children's Cold & Cough Relief
Other Information (Other information)

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store at 20-25ºC (68-77ºF)
  • do not refrigerate
  • protect from light

Daytime

  • each 10 mL contains: 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Purpose for Daytime

Antihistamine

Cough suppressant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

Nighttime

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C Blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Daytime

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Purpose for Nighttime

Antihistamine / Cough suppressant

Nasal Decongestant

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Dimetapp® Cold & Cough & Nighttime Cold & Congestion††

Children's Cold & Congestion Relief

DIPHENHYDRAMINE HCl 12.5 mg /

ANRIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCl 5 mg /

NASAL DECONGESTANT

Nighttime

Alcohol Free

  • Relieves stuffy nose, runny nose, sneezing, itchy & watery eyes & coughing

AGES 6 YEARS & OLDER

Grape flavor

DOSING CUP INCLUDED

AGES 6 + YEARS

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

††This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Nighttime Cold & Congestion.

DAYTIME

Children's Cold & Cough Relief

BROMPHENIRAMINE MALEATE 2 mg

ANTIHISTAMINE

DEXTROMETHORPHAN HBr 10 mg /

COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg /

NASAL DECONGESTANT

Daytime

Alcohol Free

  • Relieves nasal congestion, runny nose, itchy & watery eyes, sneezing & coughing

AGES 6 YEARS & OLDER

Grape flavor

FL OZ (mL)

††This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Children's Dimetapp® Cold & Cough.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using These Products (When using these products)

Nighttime

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

Daytime

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedative 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)

Nighttime

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with a 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

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve 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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Nighttime

ask a health professional before use.

Daytime

ask a health professional before use

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

Nighttime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Nighttime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that last as occurs with smoking,asthma, chronic bronchitis or emphysema

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredients for Daytime (in Each 10 Ml) (Active ingredients for Daytime (in each 10 mL))

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10mg 

Phenylephrine HCl 5 mg

Active Ingredients for Nighttime (in Each 10 Ml) (Active ingredients for Nighttime (in each 10 mL))

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg 

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

Nighttime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

Daytime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:11.060109 · Updated: 2026-03-14T23:03:07.791514