Label: COLD MEDICINE XL3- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
- NDC Code(s): 76095-011-20
- Packager: Midway Importing, Inc.
- 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.
Drug Label Information
Updated July 18, 2022
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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
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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:76095-011 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:76095-011-20 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 final part341 06/27/2022 Labeler - Midway Importing, Inc. (611851627)