Label: COLD MEDICINE XL3- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
- NDC Code(s): 63654-605-20
- Packager: Selder, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 17, 2024
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- Active ingredients (in each tablet)
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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
Alergy 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
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Do not use
■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ if you are taking a 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 adoctor before use if you have
- Ask a doctor or pharmacist before use if you
- When using this product
- Stop use and ask a doctor if
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Keep out of reach of children
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or 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.
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Directions
■ Do not use more than directed ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.
- Other Information
- Inactive Ingredients
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- Package Label
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INGREDIENTS AND APPEARANCE
COLD MEDICINE XL3
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63654-605 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 TALC (UNII: 7SEV7J4R1U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color white Score no score Shape ROUND (Tablet) Size 11mm Flavor Imprint Code XL3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63654-605-20 2 in 1 BOX 06/27/2022 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 06/27/2022 Labeler - Selder, S.A. de C.V. (824413629) Establishment Name Address ID/FEI Business Operations Selder, S.A. de C.V. 824413629 manufacture(63654-605)

