Sinus and Allergy by McKesson (Sunmark) / P & L Development, LLC DRUG FACTS

Sinus and Allergy by

Drug Labeling and Warnings

Sinus and Allergy by is a Otc medication manufactured, distributed, or labeled by McKesson (Sunmark), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SINUS AND ALLERGY- chlorpheniramine maleate, phenylephrine hcl 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

• temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• nasal congestion
• itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing
• nasal congestion

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

• take every 4 hours
• do not take more than 6 doses in 24 hours

• 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

• each tablet contains: Calcium 10 mg/ tablet
• store at 15o - 30o C (59o- 86o F)

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

 

Sinus and allergy tablets

SINUS AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-985
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	T127
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-985-04	1 in 1 CARTON	12/07/2011	12/31/2019
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/07/2011	12/31/2019

Labeler - McKesson (Sunmark) (177667227)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 96b83f21-6917-4bb7-9a0c-3de94a3b5f6d

34390-5

Set id: 5c13b414-86b8-4aa2-9052-d78f91f3f874

Version: 2

Effective Time: 20181227