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Cold and Allergy by Chain Drug Consortium

Medically reviewed on December 25, 2017

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg, CHLORPHENIRAMINE MALEATE 4mg
Labeler: Chain Drug Consortium
NDC Code: 68016-233

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.

Drug Facts

Active ingredient

Phenylephrine HCl 10 mg
Chlorpheniramine maleate 4mg

Purpose

Nasal Decongestant
Antihistamine

Uses

temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergiesrunny nose ■ sneezing ■ itching of nose or throat ■ itchy, watery
eyes ■ nasal congestion ■ sinus congestion and pressure

Warnings

Do Not Use

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 ■diabetes heart diseasehigh blood pressurethyroid disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not use more than directed ■ may cause excitability, especially in children ■ may cause
drowsiness; alcohol, sedatives or tranquilzers may increase drowsiness effect ■avoid alcoholic beverages and use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding

ask a health professional before use

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

Directions

Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. do not take more than 6 doses in 24 hours
Children under 12 years of age: Consult a doctor

Other Information

store at room temperature

Inactive Ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid

Package/Label Principal Display Panel
COLD AND ALLERGY 
phenylephrine hcl and chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-233
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint CodeT127
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-233-8224 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705LABEL(68016-233), MANUFACTURE(68016-233), PACK(68016-233), RELABEL(68016-233), REPACK(68016-233)

 
Chain Drug Consortium

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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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