Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID cbbec807-f882-4c6a-b1cd-c7fd5ce70cad

Route

ORAL

Published

Effective Date 2024-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (6.25 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-12-31

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine/Cough suppressant Nasal decongestant

Description

Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg

Uses

temporarily relieves
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritations as may occur with a cold

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

Do not give more than 6 doses in 24 hours unless directed by a doctor.
measure only with dosing cup provided Do not use any other dosing device
keep dosing cup with product
mL=mililiter
shake well before using

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years of age	do not use

Do Not Use

in a child under 4 years of age
in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Package Label

SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor

Other Information

each 5 mL contains: sodium 3 mg
store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Children's Triaminic® NightTime Cold & Cough active ingredients*

Childrens's Nighttime

Cold & Cough Relief

FOR AGES 6-11 YEARS

Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

GRAPE FLAVOR

Relief of: Cough, runny, stuffy nose itchy throat
Alcohol-Free

FL OZ (mL)

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

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product,

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

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 5 Ml)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedative or tranquilizers.

Structured Label Content

Uses

temporarily relieves
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritations as may occur with a cold

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Directions

Do not give more than 6 doses in 24 hours unless directed by a doctor.
measure only with dosing cup provided Do not use any other dosing device
keep dosing cup with product
mL=mililiter
shake well before using

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years of age	do not use

Do Not Use (Do not use)

in a child under 4 years of age
in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Package Label

SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor

Other Information

each 5 mL contains: sodium 3 mg
store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Children's Triaminic® NightTime Cold & Cough active ingredients*

Childrens's Nighttime

Cold & Cough Relief

FOR AGES 6-11 YEARS

Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

GRAPE FLAVOR

Relief of: Cough, runny, stuffy nose itchy throat
Alcohol-Free

FL OZ (mL)

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

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product, (When using this product,)

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

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

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

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 5 Ml) (Active ingredients (in each 5 mL))

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedative or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritations as may occur with a cold", "Purposes": "Antihistamine/Cough suppressant Nasal decongestant", "Directions": "Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided Do not use any other dosing device keep dosing cup with product mL=mililiter shake well before using Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years do not use unless directed by a doctor children under 4 years of age do not use ", "Do not use": "in a child under 4 years of age in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy", "Package Label": "SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor", "Other Information": "each 5 mL contains: sodium 3 mg store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST", "Principal Display Panel": "Compare to Children's Triaminic® NightTime Cold & Cough active ingredients* Childrens's Nighttime Cold & Cough Relief FOR AGES 6-11 YEARS Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant Phenylephrine HCl 2.5 mg - Nasal Decongestant GRAPE FLAVOR Relief of: Cough, runny, stuffy nose itchy throat Alcohol-Free FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsLLC.com", "When using this product,": "do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache. These could be signs of a serious condition.", "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 5 mL)": "Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg", "Ask a doctor before use if the child has": "heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma a breathing problem such as chronic bronchitis", "Ask a doctor or pharmacist before use if the child is": " taking sedative or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:06.204281 · Updated: 2026-03-14T23:02:58.626725