Label: COLD MEDICINE XL3- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63654-600-02, 63654-600-68 - 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.
Drug Label Information
Updated October 20, 2011
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
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WHEN USING
When using this product
• you may get drowsy • avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor
If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor
If pregnant or breast feeding, ask a health professional before use
- KEEP OUT OF REACH OF CHILDREN
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SPL UNCLASSIFIED SECTION
Drug Interaction Precautions
• Do not use if you are 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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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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:63654-600 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 4 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color yellow (light yellow) Score no score Shape ROUND (Tablet) Size 5mm Flavor Imprint Code XL;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63654-600-68 20 in 1 BLISTER PACK 2 NDC:63654-600-02 25 in 1 BLISTER PACK 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) Establishment Name Address ID/FEI Business Operations Selder, S.A. de C.V. 824413629 manufacture