COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Cold Medicine by

Drug Labeling and Warnings

Cold Medicine by is a Otc medication manufactured, distributed, or labeled by Selder, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves:

■ minor aches and pains

■ headaches

■ nasal congestion

■ sinus congestion & pressure

■ runny nose

■ sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 12 tablets in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product.

Allergy alert:  Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

■ if you are allergic to acetaminophen

■ more than 10 days unless directed by a doctor

■ 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

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ glaucoma

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

■ are taking the blood thinning drug warfarin

■ are taking sedatives or tranquilizers

When using this product

■ do not use more than directed

■ excitability may occur, especially in children

■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ redness or swelling is present  

■ new symptoms occur  

■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days

■ fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.  In case of overdose, contact a Poison Control Center (1-800-222-1222) immediately.

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

Directions

■ Do not use more than directed

■ Adults and children 12 years of age and older: take 2 tablets every 6 hours.  Do not take more than 12 tablets in 24 hours.

■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

■ store at room temperature in a dry place

■ do not use if blister package is torn.

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions and comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Principal Display Panel

XL-3 Cold Medicine

 

INGREDIENTS AND APPEARANCE

COLD MEDICINE 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63654-275
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63654-275-20	2 in 1 CARTON	11/15/2011
1		10 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	11/15/2011

Labeler - Selder, S.A. de C.V. (824413629)