Label: SINU-PHEN PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
- NDC Code(s): 84269-2546-1, 84269-2546-2
- Packager: Wildman Business Group
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 1, 2024
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- Official Label (Printer Friendly)
- 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
- 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.
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.
- 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.
- for more than 10 days unless directed by a doctor
ASK DOCTOR
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- trouble urinating due to an enlarged prostate gland
ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
STOP USE
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms appear
These could be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label
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INGREDIENTS AND APPEARANCE
SINU-PHEN PLUS SINUS PAIN AND PRESSURE
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84269-2546 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 CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) 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 (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code AZ;261 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84269-2546-2 125 in 1 BOX 07/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:84269-2546-1 50 in 1 BOX 07/01/2024 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 Drug M012 07/01/2024 Labeler - Wildman Business Group (016677338) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 MANUFACTURE(84269-2546) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 PACK(84269-2546) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 PACK(84269-2546)
