ALA-HIST AC- codeine phosphate, phenylephrine hydrochloride liquid 
Poly Pharmaceuticals

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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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

Purpose

Antitussive

Nasal Decongestant

Uses

Temporarily 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 information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bubble 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 Packaging

The 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 LIQUID Packaging
ALA-HIST AC LIQUID Packaging

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 (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-901-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/201002/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/200702/01/2018
Labeler - Poly Pharmaceuticals (198449894)

Revised: 2/2018
Document Id: 64a7d92d-0993-04cc-e053-2a91aa0a72b6
Set id: ac3d3783-0889-4aab-9d2e-fab799a25f20
Version: 2
Effective Time: 20180207
 
Poly Pharmaceuticals