Label: RELIEF-PE- acetaminophen, phenylephrine, chlorpheniramine tablet, coated
- NDC Code(s): 50332-0153-4, 50332-0153-7
- Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg of acetaminophen 24 hours
- with other drugs containing acetaminophen
- 3 or more alcohol drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
-
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
Stop use and ask a doctor if
- an allergic reaction occurs, seek medical help right away
- you get nervous, dizzy or sleepless
- new symptom occur
- fever worsens or lasts for more than 3 days
- pain or nasal congestion gets worse or lasts more than 7 days
- redness or swelling is present
These could be signs of serious condition
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
OVERDOSAGE
Overdose warning:
Taking more than 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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RELIEF-PE
acetaminophen, phenylephrine, chlorpheniramine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0153 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 HYDROCHLORIDE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) 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:50332-0153-4 100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 04/16/2012 2 NDC:50332-0153-7 250 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 04/16/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 04/16/2012 Labeler - HART Health (069560969) Registrant - HART Health (069560969) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 manufacture(50332-0153)