NDC | 52904-455-02, 52904-455-06, 52904-455-50 |
Set ID | 9196d2e1-c3ef-4b46-b10b-bbab08229cbb |
Category | HUMAN OTC DRUG LABEL |
Packager | Select Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE
-
INDICATIONS
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
-
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 • A persistent cough may be a sign of a serious condition
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. • 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 for pain unless directed by a doctor • for more than 3 days for fever unless directed by a
doctor • when using this product do not exceed the recommended dose. Ask a doctor before use if you
have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urinating due to an enlarged
prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where
cough is accompanied by excessive phlegm (mucus)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 • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache - PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SINUS RELIEF SEVERE CONGESTION
acetaminophen,guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-455 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color pink (blossom pink) Score no score Shape ROUND (FR14) Size 12mm Flavor Imprint Code FR14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-455-50 25 in 1 BOX 10/15/2012 1 NDC:52904-455-06 1 in 1 CARTON 1 NDC:52904-455-02 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 10/15/2012 Labeler - Select Corporation (053805599) Establishment Name Address ID/FEI Business Operations Select Corporation 053805599 label(52904-455) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(52904-455)