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Name:Alahistdm
Manufacturer:Poly Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ALAHIST DM LIQUID

ALAHIST DM - brompheniramine maleate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid 
Poly Pharmaceuticals, Inc.

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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ALAHIST DM LIQUID

Drug Facts

Active ingredients                        Purpose
(in each 5 mL teaspoonful)

Brompheniramine Maleate 4 mg ............ Antihistamine
Dextromethorphan Hydrobromide 15 mg..... Antitussive
Phenylephrine Hydrochloride 7.5mg....... Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • 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

  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, 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 condition.
  • 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 Poison Control Center immediately.

Directions

Do not exceed recommended dosage.
Adults and children 12 years of age and over:   
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hour period
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 a 24 hour period
Children under 6 years of age:
Use not recommended

Other information

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

Inactive ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Strawberry Flavor.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.
Call 1-800-882-1041
Mon.-Fri. (8 a.m. to 5 p.m. CST).

PRODUCT PACKAGING

The packaging below represents the labeling currently used:


Principal Display Panel and Side Panel for 473mL Label:

NDC 50991-814-16

ALAHIST DM LIQUID

Antihistamine / Antitussive
Decongestant

Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate........... 4 mg
Dextromethorphan HBr............... 15 mg
Phenylephrine HCl.................... 7.5 mg

Strawberry Flavor

SUGAR FREE / ALCOHOL FREE
DYE 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 is not to be dispensed to consumer.

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed by: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 11/09


Principal Display Panel and Side Panel for 15 mL Label:

NDC 50991-814-15

ALAHIST DM LIQUID

Antihistamine / Antitussive / Decongestant

Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate ............ 4 mg
Dextromethorphan HBr................ 15 mg
Phenylephrine HCl......................7.5 mg

Strawberry Flavor
Professional Sample: Not For Sale
Sugar Free / Alcohol Free / Dye Free
1/2 fl oz (15 mL)

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

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

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Distributed for:

Poly Pharmaceuticals, Mobile AL
36619

Iss. 11/09


Alahist DM Packaging

Alahist DM Packaging

Alahist DM Packaging

Alahist DM Packaging

Alahist DM Packaging


ALAHIST  DM
brompheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-814
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 7.5 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50991-814-15 12 BOTTLE ( BOTTLE) in 1 TRAY contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the TRAY (50991-814-15)
2 NDC:50991-814-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/27/2007

Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture

Revised: 01/2010 Poly Pharmaceuticals, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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