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ALA-HIST AC

Dosage form: liquid
Ingredients: Codeine Phosphate 10mg in 5mL, Phenylephrine Hydrochloride 7.5mg in 5mL
Labeler: Poly Pharmaceuticals
NDC Code: 50991-901

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.

ALA-HIST AC

DRUG FACTS Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 10 mg
*(WARNING:  May be habit forming)
Phenylephrine Hydrochloride 7.5 mg

PurposeAntitussive
Nasal Decongestant

UsesTemporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies:
  • 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 cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product
  • may cause or aggravate constipation

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 4-6 hours, not to
exceed 6 teaspoonfuls
in 24 hours
Children 6 to
under 12 years
of age:

1/2 teaspoonful (2.5 mL)
every 4-6 hours, not to
exceed 3 teaspoonfuls
in 24 hours
Children under
6 years of age:
Consul a doctor.

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 informationStore at 59°-86°F (15°-30°C)

Inactive ingredientsBubble Gum Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti 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 PackagingThe packaging below represent the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 50991-901-16

ALA-HIST AC
LIQUID

Antitussive · Nasal Decongestant
Alcohol Free · Dye Free
Sugar Free · Gluten Free


Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate*...............................10 mg
*(WARNING:  May be habit forming)
Phenylephrine HCl.................................7.5 mg

Tutti Frutti Flavor

CV

Distributed by:
Poly Pharmaceuticals
Quitman, MS  39355

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 THE CONSUMER.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

Distributed for:  Poly Pharmaceuticals, Quitman, MS  39355

Iss. 12/11









ALA-HIST  AC
codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-901
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-901-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/2007
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 02/2012
 
Poly Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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