Phenylhistine DH description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Phenylhistine DH

Qualitest Pharmaceuticals

PHENYLHISTINE DH CV


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Chlorpheniramine maleate, USP 2 mg

Codeine phosphate, USP 10 mg

Pseudoephedrine HCl, USP 30 mg

Antihistamine

Cough suppressant

Nasal decongestant

  • 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

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.

  • 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.

store at 15° to 30°C (59° to 86°F)

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

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. 11/09 R6
8070590 1520

PRINCIPAL DISPLAY PANEL

Phenylhistine DH

Phenylhistine DH

chlorpheniramine maleate and codeine phosphate and pseudoephedrine hcl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-1520
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 10 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
MENTHOL
water
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SODIUM CHLORIDE
sorbitol
SUCROSE

Product Characteristics

Color
PURPLE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-1520-54 118 in 1 BOTTLE, PLASTIC
2 NDC:0603-1520-58 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1996-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.