NIGHTTIME CHILDRENS MULTI SYMPTOMS COLD AND COUGH MULTI-SYMPTOM RELIEF- chlorpheniramine maleate and dextromethorphan hydrobromide solution

Nighttime Childrens Multi Symptoms by

Drug Labeling and Warnings

Nighttime Childrens Multi Symptoms by is a Otc medication manufactured, distributed, or labeled by WAL-MART STORES,INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL)	Purpose
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan HBr 15 mg	Cough suppressant

Uses

temporarily relieves cold symptoms:

• ▪ cough due to minor throat & bronchial irritation
• ▪ sneezing
• ▪ runny nose

Warnings

Do not use

• ▪ 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.
• ▪ to make a child sleep

Ask a doctor before use if you have

• ▪ glaucoma
• ▪ cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• ▪ trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• ▪ excitability may occur, especially in children
• ▪ marked drowsiness may occur
• ▪ avoid alcoholic drinks
• ▪ be careful when driving a motor vehicle or operating machinery
• ▪ alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• cough persists more than 1 week, tends to recur or is accompanied by 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 right away at 1-800-222-1222.

Directions

• take only as directed
• do not exceed 4 doses per 24 hrs.
• only use the dose cup provided

• adults & children 12 yrs & over:

  30 mL every 6 hrs.

• children 6 to under 12 yrs:

  15 mL every 6 hrs.

• children 4 to under 6 yrs:

  do not use unless directed by a doctor

• children under 4 yrs:

  do not use

Other information

• each tablespoon contains:potassium 5 mg sodium 5 mg
• store at room temperature

Inactive ingredients

Anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

Compare to the active ingredients in Children’s Vicks Nyquil™*

NDC: 49035-545-08

Nighttime Children’s Multi-Symptoms
Cold & Cough

Chlorpheniramine maleate 2 mg,

Dextromethorphan HBr 15 mg

• Sneezing
• Runny Nose
• Cough

Sugar Free, Aspirin Free

Natural Cherry Flavor

Free of Alcohol & Acetaminophen

8 FL OZ (236 ml)

Distributed by:

Mae in the USA

With domestic and imported ingredients Factory Certified

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.

*This product is manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks® Nyquil™

INGREDIENTS AND APPEARANCE

NIGHTTIME CHILDRENS MULTI SYMPTOMS  COLD AND COUGH MULTI-SYMPTOM RELIEF
chlorpheniramine maleate and dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-545
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY (Natural Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-545-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/2020

Labeler - WAL-MART STORES,INC. (051957769)