SINUS AND ALLERGY- chlorpheniramine maleate, phenylephrine hcl tablet

Sinus and Allergy by

Drug Labeling and Warnings

Sinus and Allergy by is a Otc medication manufactured, distributed, or labeled by EQUALINE (SuperValu). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 care 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

• 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-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

Compare to Maximum Strength Sudafed PE® Sinus & Allergy active ingredients*

Sinus & Allergy PE

Chlorpheniramine Maleate / Phenylephrine HCl

antihistamine / nasal congestion

tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. owner of the registered trademark Sudafed PE® Sinus & Allergy

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN  55344 USA

PRODUCT OF USA

Product Label

Equaline Sinus & Allergy PE Tablet

INGREDIENTS AND APPEARANCE

SINUS AND ALLERGY 
chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-810
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: 41163-810-24	1 in 1 CARTON	12/07/2011	12/07/2020
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	12/07/2020

Labeler - EQUALINE (SuperValu) (006961411)