Label: PAIN AND SINUS RELIEVER- acetaminophen and phenylephrine tablet
- NDC Code(s): 67060-194-67, 67060-194-68
- Packager: ADVANCED FIRST AID, INC.
- 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 January 7, 2023
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- ACTIVE INGREDIENT
- PURPOSE
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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 freer breathing
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, which is the maximum daily amount • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Alergy 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.
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.
• 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 prouct.
Ask a doctor or pharmacist before use if: • you are taking the blood thinning drug warfarin.
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 • liver disease •high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
When using this product do not exceed recommended dose.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN AND SINUS RELIEVER
acetaminophen and phenylephrine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-194 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue (LIGHT BLUE) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-194-68 100 in 1 CARTON 04/09/2015 08/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:67060-194-67 250 in 1 CARTON 04/09/2015 08/01/2024 2 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 04/09/2015 08/01/2024 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-194) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-194)