CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid
Family Dollar (FAMILY WELLNESS)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

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 irritation as may occur with a cold

Warnings

Do not use

to make a child sleepy
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 contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the chld has

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

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

do not use more than directed
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop use and ask a doctor if

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

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
tsp=teaspoon, mL=milliliter

age	dose
children 6 to 11 years	2 tsp 910 mL) every 4 hours
children 4 to 5 years	do not use unless directed by a doctor
children under 4 years	do not use

Other information

each 5 mL contains: sodium 6 mg
contains no aspirin
protect from light
store at 20º-25º (68º-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, benzoic acid, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, maltitol solution, natural and artificial flavor, propylene glycol, purified water, sodium citrate

Questions oe comments

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

Principal Display Panel

Ages 6 to 11

Compare to active ingredients of children's Triaminic® Night Time Cold & Cough*

Children's

Night Time

Cold & Cough

Nighttime

Diphenhydramine HCl-Antihistamine/ Cough suppressant

Phenylephrine HCl-Nasal decongestant

Grape flavor

FL OZ (mL)

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

VISIT FAMILYDOLLAR.COM

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

PRODUCT OF USA

Package Label

Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

Family Wellness Childrens Cold & COugh Nighttime

CHILDRENS NIGHTTIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-379
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55319-379-04	1 in 1 BOX	07/31/2014	01/31/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/31/2014	01/31/2020

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 4/2019

Document Id: d38429dd-1947-4826-83c8-5f4c32dd4798

Set id: 68ab8a28-2365-43c0-8e57-c7c03ffcc8b9

Version: 3

Effective Time: 20190409

Family Dollar (FAMILY WELLNESS)