Label: RELIEF-PE- acetaminophen, phenylephrine, chlorpheniramine tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 50332-0127-4, 50332-0127-7 - Packager: NorMed
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 16, 2012
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- WARNINGS
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DO NOT USE
Do not use:
- with any other drug containing acetaminophen (prescription or non-prescription)
- 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, or if you do not know if your prescription drug contains an MAOI
- ASK DOCTOR/PHARMACIST
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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OVERDOSAGE
Overdose warning: Taking mo rethan the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.
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DOSAGE & ADMINISTRATION
Directions: Do not take more than directed. Adults and children 12 years of age an over:
- take 1 to 2 tablets every 6 hours while symptoms persist
- do not take more than 8 tablets in 24 hours unless directed by a doctor
- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RELIEF-PE
acetaminophen, phenylephrine, chlorpheniramine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE 2 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ275 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0127-4 100 in 1 BOX, UNIT-DOSE 2 NDC:50332-0127-7 250 in 1 BOX, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/16/2012 Labeler - NorMed (069560969)