Multi Symptom Cold Allergy Tabs

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 2mg, CHLORPHENIRAMINE MALEATE 5mg
Labeler: Contract Pharmacal Corp
NDC Code: 10267-0316

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.

MULTI-SYMPTOM COLD & ALLERGY TABS

Drug Facts

Active Ingredient

(in each tablet)
Acetaminophen 325 mg
Chlorpheniramine Maleate 2 mg
Phenylephrine 5 mg

Purposes

Analgesic, Antipyretic
Antihistamine
Nasal Decongestant

Uses
  • for temporary relief of  headaches, nasal congestion, runny nose, sore throat, fever and minor aches and pains due to cold
  • for sneezing and itchy, watery eyes due to hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure and reduces swelling of nasal passages

Warnings

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

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)
  • for 2 weeks after stopping the MAOI drug
  • if you are uncertain whether your prescription drug contains an MAOI
  • for more than 7 days

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Stop use and ask a doctor if
  • symptoms do not improve or are accompanied by a fever that lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • sore throat is severe, persists for more than 2 days or is accompanied or followed by fever, headache, rash, nausea or vomiting
  • nervousness, dizziness or sleeplessness occurs

When using this product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years of age and oldertake 2 tablets every  4 hours, do not exceed 12 tablets in 24 hours
children under 12 years of ageconsult a physician

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at room temperature, USP

Inactive Ingredients

Corn Starch, Croscarmellose Sodium, D&C Yellow #10 Lake, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Silica, Sodium Starch Glycolate and Stearic Acid

*This product is not manufactured or distributed by Whitehall-Robins Healthcare, owner of the registered trademark Dristan® Multi Symptom Formula. Manufactured by

CONTRACT PHARMACAL CORP., Hauppauge, NY 11788 USA / www.CPCHealth.com

R 02/08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MULTI SYMPTOM COLD ALLERGY TABS 
acetaminophen chlorpheniramine maleate phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-0316
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM ALUMINUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorYELLOW (Pale yellow) , WHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 316
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-0316-1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/14/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 01/2012
 
Contract Pharmacal Corp

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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