COLD AND COUGH CHILDRENS- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Cold and Cough by

Drug Labeling and Warnings

Cold and Cough by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Brompheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Antihistamine
Cough suppressant
Nasal decongestant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold
  
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  
  • itchy, watery eyes
  • runny nose
  • sneezing
    
  • itching of the nose or throat
    
• temporarily restores freer breathing through the nose
  

Warnings

Do not use

• 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.
  

Ask a doctor before use if you have

• diabetes
• heart disease
• thyroid disease
• high blood pressure
  
• glaucoma
• cough that occurs with too much phlegm (mucus)
  
• difficulty in urination due to enlargement of the prostate gland
  
• a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not exceed recommended dosage
  
• marked drowsiness may occur
  
• avoid alcoholic beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• use caution when driving a motor vehicle or operating machinery
  
• 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 are accompanied by fever
  
• cough persists more than 7 days, tends to recur, 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.

Directions

• mL = milliliter; FL OZ = fluid ounce
  
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• do not take more than 6 doses in any 24-hour period

• Age: Dose
• adults and children 12 years and over: 20 mL every 4 hours
• children 6 to under 12 years: 10 mL every 4 hours
• children under 6 years: do not use

Other information

• each 10 mL contains: sodium 5 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number
  

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions or comments?

1-800-426-9391

Principal display panel

VALUE SIZE

CVS
Health™

Compare to the active
ingredients in Children's
Dimetapp® Cold & Cough*

Grape Flavor

Children's
Cold &
Cough

BROMPHENIRAMINE
MALEATE
Antihistamine
DEXTROMETHORPHAN HBr
Cough Suppressant
PHENYLEPHRINE HCl
Nasal Decongestant

Liquid

Relieves:
Nasal congestion, Stuffy nose,
Runny nose, Sneezing
Soothes cough

Alcohol free

Grape Flavor
For Ages 6 Years & Over

Actual Bottle Size
on Side Panel

8 FL OZ (237 mL)

Package Contains One Bottle
Actual Size

CVS Health™ Children’s Cold & Cough
offers grape-favored relief from nasal
congestion, runny nose, coughing and
sneezing to get through the day.

*This product is not manufactured or distributed
by Wyeth LLC, owner of the registered trademark
Children’s Dimetapp® Cold & Cough.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849

CVS®Quality
Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen drug abuse
www.StopMedicineAbuse.org

CVS Health 44-040

INGREDIENTS AND APPEARANCE

COLD AND COUGH  CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-940
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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: 69842-940-19	1 in 1 CARTON	07/02/2018	04/15/2022
1		237 mL in 1 BOTTLE, PLASTIC; 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	07/02/2018	04/15/2022

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(69842-940) , PACK(69842-940)