SINUS AND ALLERGY- chlorpheniramine maleate and phenylephrine hydrochloride tablet 
Mckesson (Sunmark)

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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DRUG FACTS

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

  • high blood pressure
  • heart disease
  • glaucoma
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by a fever

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: 1-800-222-1222

Directions

 adults and children 12 years of age and older take 1 tablet
 children 6 to under 12 years of age take 1/2 tablet
 children under 6 years of age consult a doctor
 children under 4 years of age do not use

Other information

Inactive ingredients

colloidal silicon dioxide, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, sodium starch glycolate and stearic acid.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Compare to maximum strength sudafed PE® sinus &allergy active ingredients*

*This product is not manufactured or distributed by McNeil consumer healthcare, Division of McNeil-PPC, Inc. owner of the registered trademark Sudafed PE® Sinus and allergy

Maximum Strength Sinus & Allergy

For relief of: sinus pressure, sinus & nasal congestion, sneezing, itchy, watery eyes.

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Product Label

 Sunmark maximum strength sinus and allergy tablets

Sinus and allergy tablets

SINUS AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-985
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 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 Code T127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-985-041 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/07/2011
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: bb339ab4-5255-4a08-af7d-132e5c3b4231
Set id: 5c13b414-86b8-4aa2-9052-d78f91f3f874
Version: 1
Effective Time: 20120920
 
Mckesson (Sunmark)