![SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL 325 MG, 200 MG AND 5 MG) TABLET, COATED [WE CARE DISTRIBUTOR INC.]](https://medic.hrt.org//dailymed/images/1f6fb7c8-d3f6-4e1f-9da1-4a7d6ea90f1b/Sinus.jpg)
| NDC | 70005-012-02, 70005-012-25, 70005-012-50 |
| Set ID | 1f6fb7c8-d3f6-4e1f-9da1-4a7d6ea90f1b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | We Care Distributor Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- for the temporary relief of:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies
- temporarily reduces fever
-
Warnings
Liver warning:
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. 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
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 monomine 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
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis,or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition
Keep out of reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- Other information
- Inactive ingredients
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Questions or comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SINUS CONGESTION AND PAIN RELIEF
acetaminophen, guaifenesin and phenylephrine hcl 325 mg, 200 mg and 5 mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color pink Score no score Shape OVAL Size 12mm Flavor Imprint Code FR;14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-012-25 25 in 1 BOX 02/15/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-012-50 50 in 1 BOX 02/15/2016 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-012-02 2 in 1 POUCH 02/15/2016 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/15/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(70005-012)
