COLD AND ALLERGY MAXIMUM STRENGTH- chlorpheniramine maleate, phenylephrine hcl tablet

Cold and Allergy by

Drug Labeling and Warnings

Cold and Allergy by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). 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
  • nasal congestion
  • itching of the nose or throat
  • itchy, watery eyes 
• 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
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• do not use more than directed
• excitability may occur, especially in children
• drowsiness may occur,  
• avoid alcoholic drinks 
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful 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 occur with 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 any 24 hour period

• 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

Inactive ingredients

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

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredients of Actifed® Cold & Allergy*

Maximum Strength

Cold & Allergy

Chlorpheniramine Maleate 4 mg/Antihistamine

Phenylephrine HCl 10 mg/Nasal Decongestant

Pseudoephedrine Free

Nasal Congestion Runny Nose

Sneezing Itchy, Watery Eyes

Tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072

Product Label

DOLLAR GENERAL Maximum Strength Cold & Allergy

INGREDIENTS AND APPEARANCE

COLD AND ALLERGY  MAXIMUM STRENGTH
chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-890
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, ANHYDROUS (UNII: L11K75P92J)
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: 55910-890-48	2 in 1 CARTON	04/30/2013
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55910-890-24	24 in 1 CARTON	04/30/2013
2		1 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	04/30/2013

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)