Label: COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
- NDC Code(s): 63654-275-20
- Packager: Selder, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 25, 2017
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- Active ingredients (in each tablet)
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
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
■ high blood pressure
■ thyroid disease
■ 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
■ 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
- Inactive ingredients
- Questions and comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
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 FINAL part341 11/15/2011 Labeler - Selder, S.A. de C.V. (824413629)