SINE OFF SINUS/COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

SINE OFF by

Drug Labeling and Warnings

SINE OFF by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

PURPOSE

Purposes

Pain reliever / fever reducer

Antihistamine

Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms due to the common cold:
• headache
• sinus congestion and pressure
• nasal congestion
• minor aches and pains
• temporarily relieves thes additional symptoms of hay fever and other upper respiratory allergies:
• itching of the nose and throat
• itchy, watery eyes
• runny nose and sneezing
• helps clear nasal passages
• helps decongest sinus openings and passages
• temporarily reduces fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg 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

• 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 ingredients in this products
• if you are now taking a 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
• diabetes
• difficulty in urination due to enlargement of the prostrate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

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 or swelling is present
• new symptoms occur

These could be signs of a serious condition.

If pregnant or breast feeding, ask a health professional before use.

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

Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years and older:
• take 2 caplets every 6 hours as needed
• swallow whole - do not crush, chew or dissolve
• do not take more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

SPL UNCLASSIFIED SECTION

Other information

• store at room temperature in a dry place
• avoid excessive heat and humidity
• retain carton for complete product information

INACTIVE INGREDIENT

Inactive ingredients Croscarmellose sodium, crospovidone, D&C yellow #10, FD&C yellow #6, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin.

QUESTIONS

Questions? If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898.

SPL UNCLASSIFIED SECTION

DO NOT USE IF CARTON IS OPEN OR IF SEALED BLISTER UNITS ARE BROKEN OR DAMAGED.

Manufactured by:

Gemini Pharmaceuticals, Inc.

Commack, NY 11725

PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION

Strong, Fast Relief!
SINE® OFF

SINUS/COLD MEDICINE

• Sinus Headache
• Pain / Fever
• Sinus Pressure
• Nasal Congestion
• Runny Nose
• Sneezing
• Itchy, Watery eyes

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).
Each Caplet Contains:

Acetaminophen 500 mg.................Pain reliever / fever reducer
Chlorpheniramine maleate 2 mg.............................Antihistamine
Phenylephrine HCl 5mg................................Nasal decongestant
24 CAPLETS

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, UNSPECIFIED (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)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)

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	07/05/2010	03/31/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51645-291-24	2 in 1 BOX	07/05/2010
2		12 in 1 BLISTER PACK; 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	07/05/2010

Labeler - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture(51645-291)