Your browser does not support JavaScript! COUGH AND COLD (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ACCUDIAL PHARMACEUTICAL, INC.]
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RxNorm Names

COUGH AND COLD (chlorpheniramine maleate and dextromethorphan hydrobromide) liquid
[Accudial Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

COUGH & COLD LONG-ACTING

Drug Facts

Active ingredients
(in each 5 mL tsp)
Purposes
Chlorpheniramine maleate, USP 1 mgAntihistamine
Dextromethorphan HBr, USP 7.5 mgCough suppressant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

Do not use

  • to sedate a child or 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 the child has

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a 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

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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, 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.

Directions

  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
agedose
under 6 yearsdo not use
6 to under 12 years1-2 tsp. (5-10 mL) every 6 hours

Other information

  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Cough & Cold
Long-Acting

ACCURATE DOSING
BY WEIGHT

Chlorpheniramine Maleate
(Antihistamine)

Dextromethorphan HBr
(Cough Suppressant)

RELIEVES
Cough: Up to 8 Hours
Runny Nose

For Ages 6 to under 12

Compares to Children's
Robitussin® Cough &
Cold Long-Acting.

FRUIT
PUNCH
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-151-04

Principal Display Panel - 118 mL Carton
COUGH AND COLD 
chlorpheniramine maleate and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45014-151
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate1 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Fruit 
Citric Acid Monohydrate 
FD&C RED NO. 40 
Glycerin 
Water 
Sodium Benzoate 
Sodium Citrate 
Sorbitol 
Sucralose 
Product Characteristics
ColorRED (Reddish-Pink) , PINKScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45014-151-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/25/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 11/2009
 
Accudial Pharmaceutical, Inc.

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