Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID a7847413-e556-4f88-8a7f-a8528afbe927

Route

ORAL

Published

Effective Date 2023-10-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg) Phenylephrine (5 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Anhydrous Citric Acid Acesulfame Potassium Maltitol Edetate Disodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-03-31

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

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

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour 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 = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 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.

Package Label

WALGREENS Children's Cold & Congestion Grape Flavor

Other Information

each 10 mL contains: sodium 6mg
store at 20-25°C (68-77°F)
Do not refrigerate
protect from light

Inactive Ingredients

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

Questions Or Comments?

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

Principal Display Panel

children's

COLD & CONGESTION

DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††

Nighttime
Alcohol Free
6 years & older

FL OZ (mL)

GRAPE FLAVOR

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

DISTRIBUTED BY : WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product

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
excitability may occur, especially in children

Stop Use and Ask A Doctor If

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 a fever, rash, or persistent headache.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredients (in Each 10 Ml)

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Ask A Doctor Before Use If You Have

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

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 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

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour 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 = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 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.

Package Label

WALGREENS Children's Cold & Congestion Grape Flavor

Other Information (Other information)

each 10 mL contains: sodium 6mg
store at 20-25°C (68-77°F)
Do not refrigerate
protect from light

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

children's

COLD & CONGESTION

DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††

Nighttime
Alcohol Free
6 years & older

FL OZ (mL)

GRAPE FLAVOR

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

DISTRIBUTED BY : WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product (When using this product)

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
excitability may occur, especially in children

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

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 a 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.

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

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

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

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

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

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

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": ""}, {"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": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "Purposes": "Antihistamine/Cough suppressant Nasal decongestant", "Directions": "do not take more than 6 doses in any 24-hour 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 = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 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.", "Package Label": "WALGREENS Children's Cold & Congestion Grape Flavor", "Other information": "each 10 mL contains: sodium 6mg store at 20-25°C (68-77°F) Do not refrigerate protect from light", "Inactive ingredients": "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", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "children's COLD & CONGESTION DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients†† Nighttime Alcohol Free 6 years & older FL OZ (mL) GRAPE FLAVOR TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY : WALGREEN CO 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com", "When using this product": "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 excitability may occur, especially in children", "Stop use and ask a doctor if": "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 a fever, rash, or persistent headache. These could be signs of a serious condition.", "If pregnant or breast-feeding,": " ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredients (in each 10 mL)": "Diphenhydramine HCI 12.5 mg Phenylephrine HCI 5 mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlem (mucus) a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena. ", "Ask a doctor or pharmacist before use if you are": "taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:20.878565 · Updated: 2026-03-14T23:01:22.645369