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Alahist

Poly Pharmaceuticals, Inc.
Poly Pharmaceuticals

Alahist LQ Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients                    
(in each 5 mL teaspoonful)
                                                   
Diphenhydramine Hydrochloride 25 mg
Phenylephrine Hydrochloride 7.5 mg

Purpose



Alahist Uses


  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • do not use this with any other product containing diphenhydramine, even one used on skin
  • 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

  • a breathing problem such as emphysema or chronic bronchitis especially in children
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if you are


When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious conditions
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental overdose seek professional help or contact a Poision Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older:                    
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:
1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours.
Children under 6 years of age:
Use is not recommended.

Alahist Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients




Questions? Comments?


PRODUCT PACKAGING

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473mL Label:

NDC 50991-607-16

ALAHIST LQ LIQUID

Antihistamine / Antitussive / Decongestant

Each 5 mL (1 teaspoonful) contains:
Diphenhydramine HCl............. 25 mg
Phenylephrine HCl................. 7.5 mg

Fruit Candy Flavor

Dye Free - Sugar Free - Alcohol Free

Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619

16 fl oz. (473 mL)

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 10/09


Alahist


Alahist

Alahist

Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50991-607
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 7.5 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 NDC:50991-607-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-12-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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