Label: ALLERGY RELIEF MULTISYMPTOM- acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-457-02 - Packager: Select 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 October 15, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses: Temporarily: • relieves nasal congestion associated with sinusitis
• relieves nasal congestion due to the common cold, hay fever or other
upper respiratory allergies • relieves sinus congestion and pressure,
helps decongest sinus openings and passages • restores free breathing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passages of bothersome mucus, drain bronchial tubes, and
make coughs more productive • Temporarily relieves minor aches, pains,
and fever associated with: • headache • common cold • toothache
• backache • muscular aches • menstrual cramps
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WARNINGS
Warnings: Liver Warning: This
product contains acetaminophen. Severe liver damage may occur if
you take: • more than 8 tablets in 24 hours • with other drugs containing
acetaminophen (prescription or nonprescription). Ask a doctor or
pharmacist before using with other drugs if you are not sure. • 3 or more
alcoholic drinks every day while using this product Do not: use with
any other product containing acetaminophen this will provide more
than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns. • use more than the recommended
dose • for more than 10 days for pain unless directed by a doctor • for
more than 3 days for fever unless directed by a doctor • 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product. Stop use and ask a doctor if: • symptoms
do not improve • pain or fever persists or gets worse • new
symptoms occur • redness or swelling is present • nervousness,
dizziness or sleeplessness occur • symptoms do not improve within 7
days or are accompanied by fever Ask a doctor before use if you
have: • heart disease • high blood pressure • thyroid disease • diabetes
• difficulty in urination due to enlargement of the prostate gland • a breathing
problem such as emphysema or chronic bronchitis, or if you have glaucoma
or difficulty in urination due to enlargement of the prostate gland • may cause
excitability especially in children • may cause drowsiness; alcohol, sedatives,
and tranquilizers may increase the drowsiness effect • avoid alcoholic
beverages while taking this product • do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor • use
caution when operating machinery. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF MULTISYMPTOM
acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-457 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 POVIDONE K29/32 (UNII: 390RMW2PEQ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (snow white) Score no score Shape ROUND (FR11) Size 11mm Flavor Imprint Code FR11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-457-02 2 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/15/2012 Labeler - Select Corporation (053805599)