Label: PHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 0924-0091-00, 0924-0091-01
- Packager: Acme United Corporation
- Category: HUMAN OTC DRUG LABEL
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 June 10, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen 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
Allergy 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
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.■ for more than 10 days for pain unless directed by a doctor
■ for more than 3 days for fever unless directed by a doctor
■ with any other drug using the above active ingredients
■ 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. If you
do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - ASK DOCTOR
- WHEN USING
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- Questions?
- Allergy Plus Label
-
INGREDIENTS AND APPEARANCE
PHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0091 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 CROSPOVIDONE (UNII: 2S7830E561) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;275 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0091-01 50 in 1 CARTON 12/23/2011 1 NDC:0924-0091-00 2 in 1 PACKET; 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 12/23/2011 Labeler - Acme United Corporation (001180207)