Label: SINE OFF SINUS/COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 51645-291-12, 51645-291-24
- Packager: Gemini Pharmaceuticals, 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.
Updated July 2, 2010
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- Active Ingredients (in each caplet)
Chlorpheniramine maleate 2mg
Phenylephrine HCl 5mgClose
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose and throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is maximum daily amount for this product.
- 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 allergic to acetaminophen or any of the inactive ingredients in this products
- if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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.
Ask a doctor before use if you have
- Liver disease
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostrate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage.
- excitability may occur,especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness swelling is present
- new symptoms occur
Keep out of reach of children
Overdose Warning: Taking more than recommended dose (overdose) may cause liver damage. 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.
- do not take more than directed (see overdose warning)
- take 2 caplets every 4 to 6 hours as needed
- Swallow whole - do not crush, chew or dissolve.
- do not take more than 8 caplets in 24 hours.
- Do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause the liver damage.
- Other information
- Store at room temperature
- avoid excessive heat and humidity
- Retain carton for complete product information
- Inactive ingredients
Croscarmellose Sodium, Crospovidone, D&C Yellow # 10, FD&C Yellow # 6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized starch, Propylene glycol, Silicone dioxide, Stearic Acid, Titanium Dioxide, Triacetin.
- Questions or comments?
If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898Close
- Package label Sine Off Maximum Strength
See the New Warning Information
Strong, Fast Relief!
- Relieves Sinus Headache
- Runny Nose
- Itchy, Watery eyes
Acetaminophen 500mg.............Pain Reliever
Chlorpheniramine maleate 2mg....Antihistamine
Phenylephrine HCl 5mg............Nasal decongestant
- INGREDIENTS AND APPEARANCE
SINE OFF SINUS/COLD MEDICINE
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51645-291 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color yellow Score no score Shape CAPSULE (Capsule Shaped Tablet) Size 17mm Flavor Imprint Code Sine;Off;PE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51645-291-12 1 in 1 BOX 1 12 in 1 BLISTER PACK 2 NDC:51645-291-24 2 in 1 BOX 2 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 07/05/2010 Labeler - Gemini Pharmaceuticals, Inc. (055942270) Establishment Name Address ID/FEI Business Operations Gemini Pharmaceuticals, Inc. 055942270 manufacture