275 - XL-3 Cold Medicine - DailyMed

COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet  Selder, S.A. de C.V.

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275 - XL-3 Cold Medicine 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

 

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 GLYCOL, UNSPECIFIED (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 Drug M012 11/15/2011

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

Revised: 1/2017 Document Id: f7300376-dd92-4f5e-b68d-175e8023ca44 34390-5 Set id: d2762d9c-e7e7-42b2-a26a-14b2aa0307cb Version: 5 Effective Time: 20170125  Selder, S.A. de C.V.