ALAHISTDM DM- dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

ALAHIST by

Drug Labeling and Warnings

ALAHIST by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ALAHIST DM LIQUID

Drug Facts

Active ingredients

(in each 5 mL teaspoonful) 
Dexbrompheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 7.5mg

Purpose

Antihistamine
Antitussive
Nasal 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

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 the drowsiness effect
  
• 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. A persistent cough may be a sign of a serious condition.
  
• new symptoms occur

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

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 ; 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: Consult a doctor.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

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).

PRINCIPAL DISPLAY PANEL

PRODUCT PACKAGING

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473 mL Label:

NDC: 50991-826-16 

ALAHIST DM
LIQUID  

Antihistamine Antitussive
Nasal Decongestant

Each 5 mL (1 teaspoonful) contains:
Dexbrompheniramine Maleate........... 2 mg
Dextromethorphan HBr............... 15 mg
Phenylephrine HCl.................... 7.5 mg

Strawberry Flavor 

SUGAR FREE / ALCOHOL FREE
DYE FREE / GLUTEN FREE

Distributed by:
Poly Pharmaceuticals
Owens Cross Roads, AL 35763 

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.

Distributed by: Poly Pharmaceuticals, Owens Cross Roads, AL 35763

Rev. 09/16 

INGREDIENTS AND APPEARANCE

ALAHISTDM   DM
dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-826
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-826-15	12 in 1 TRAY	09/01/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50991-826-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2016

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(50991-826)