Your browser does not support JavaScript! QUENALIN COUGH (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [QUALITEST PHARMACEUTICALS, INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

QUENALIN COUGH (diphenhydramine hydrochloride) syrup
[Qualitest Pharmaceuticals, 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

Active Ingredient: Diphenhydramine hydrochloride 12.5 mg (in each 5 mL(teaspoonful)(TSP))

Purpose: Antitussive

Uses

temporarily relieves cough due to cold or bronchial irritation

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • cough accompanied by excessive phlegm (mucus)
  • breathing problems such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use

if you are  taking tranquilizers or sedatives

When using this product

  •  marked drowsiness may occur
  •  avoid alcoholic drinks
  •  excitability may occur, especially in children
  •  be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

symptoms last for more than 1 week or recurred or accompanied by fever, rash, headache

If pregnant or breast-feeding

  •  ask 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 six doses

Adults and children over 12 years
2 teaspoonfuls(TSP) every 4 hours
children under 12 years
DO NOT USE

Use only with supplied dosage cup

Other information

  • Store at room temperature 20°-25°C (68°-77°F)
  •  Protect from freezing.

Inactive ingredients:

Alcohol 5%, ammonium chloride, citric acid, D&C red no. 33, FD&C red no. 40, menthol, methylparaben, propylene glycol, propylparaben, sodium citrate, strawberry flavor, sucrose, water

Made in
USA
for QUALITEST PHARMACEUTICALS
130 VINTAGE DRIVE
HUNTSVILLE, AL 35811



Container Label


Carton Label


QUENALIN COUGH 
diphenhydramine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0860
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine hydrochloride (Diphenhydramine) Diphenhydramine hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
ammonium chloride 
anhydrous citric acid 
D&C red no. 33 
FD&C red no. 40 
menthol 
methylparaben 
propylene glycol 
propylparaben 
sodium citrate 
sucrose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (Strawberry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0860-54118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/1993
Labeler - Qualitest Pharmaceuticals, Inc (011103059)

Revised: 12/2013
 
Qualitest Pharmaceuticals, Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services