PHENYLHISTINE DH- chlorpheniramine maleate and codeine phosphate and pseudoephedrine hcl liquid 
Qualitest Pharmaceuticals

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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PHENYLHISTINE DH

CV

Active ingredients (in each 5 mL = 1 tsp)

Chlorpheniramine maleate, USP 2 mg

Codeine phosphate, USP 10 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Antihistamine

Cough suppressant

Nasal decongestant

Uses

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

Warnings

Do not use

  • in a child under 2 years of age
  • 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.
  • if you or your child has a chronic pulmonary disease or shortness of breath
  • if your child is taking other drugs, unless directed by a doctor

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such 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 use more than directed
  • constipation may occur or be aggravated
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • 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

  • you get nervous, dizzy, or have trouble sleeping
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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

  • take every 4 hours
  • do not take more than 4 doses in any 24-hour period

adults and children 12 years and over

take 10 mL (2 tsp)

children 6 years to under 12 years

take 5 mL (1 tsp)

children 2 years to under 6 years

consult a doctor

children under 2 years

do not use

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

alcohol, citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol solution, sucrose

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 2/15 R7
8070590 1520

PRINCIPAL DISPLAY PANEL

This is an image of label for Phenylhistine DH.
PHENYLHISTINE DH 
chlorpheniramine maleate and codeine phosphate and pseudoephedrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-1520
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorPURPLE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-1520-54118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/199604/30/2018
2NDC:0603-1520-58473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/199604/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/199604/30/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-1520)

Revised: 4/2015
 
Qualitest Pharmaceuticals