Kmart Corporation Children’s Nighttime Cold & Cough Drug Facts

Smart Sense Childrens Nighttime Cold and Cough by

Drug Labeling and Warnings

Smart Sense Childrens Nighttime Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl solution 
Kmart Corporation

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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Kmart Corporation Children’s Nighttime Cold & Cough Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/cough suppressant

Nasal decongestant

Uses

• temporarily relieves:
• sneezing
• itchy nose or throat
• runny nose
• 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

• 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
• to make a child sleepy

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 sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• 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 fever
• cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

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

Directions

• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
• use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

• Age:

  Dose

• children under 4 years of age:

  do not use

• children 4 to under 6 years of age:

  do not use unless

  directed by a doctor

• children 6 to under 12 years of age:

  10 mL

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

ACTIVE INGREDIENTS IN CHILLDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH

FOR AGES 6 – 12 YEARS

children’s nighttime cold & cough

TRIACTING SYRUP

ANTIHISTAMINE/COUGH SUPPRESSANT (DIPHENHYDRAMINE HCl)

NASAL DECONGESTANT (PHENYLEPHRINE HCl)

GRAPE FLAVOR

RELIEVES:

COUGH - RUNNY, STUFFY NOSE

ITCHY THROAT

4 FL OZ (118 mL)

SMART SENSE CHILDRENS NIGHTTIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-453
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-453-26	1 in 1 CARTON	04/18/2014	07/10/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/18/2014	07/10/2019

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: 8ae433c4-bb1f-4a4b-b428-b95fa37ee6e6

34390-5

Set id: fa196684-98da-47af-bd78-99d1fef06960

Version: 3

Effective Time: 20191217