Sine Off Maximum Strength

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]

SINE OFF MAXIMUM STRENGTH- acetaminophen, phenylephrine hydrochloride tablet, coated 
Gemini Pharmaceuticals, Inc.

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.

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Sine Off Maximum Strength

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever / fever reducer

Nasal decongestant

Uses

• for the temporary relief of:
• sinus congestion and pressure
• headache
• nasal congestion
• minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages
• temporarily reduces fever

Warnings

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

• more than 4,000 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 inactive ingredients in this product
• if you are now taking 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.

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage.

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

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.

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

Other information

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

Inactive ingredients Croscarmellose sodium, crospovidone, FD&C red # 40, FD&C yellow # 6, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin.

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

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

Manufactured by:

Gemini Pharmaceuticals, Inc.

Commack, NY 11725

SEE NEW WARNINGS INFORMATION

SINE OFF®

MAXIMUM STRENGTH

Non-Drowsy Relief of

• Sinus Headache
• Pain / Fever
• Sinus Pressure
• Nasal Congestion

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

Each Caplet Contains:
Acetaminophen 500mg....Pain reliever/fever reducer
Phenylephrine HCl 5mg.....Nasal decongestant
24 Caplets

SINE OFF  MAXIMUM STRENGTH
acetaminophen, phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51645-269
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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	red	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: 51645-269-12	1 in 1 BOX	07/05/2012	11/30/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51645-269-66	2 in 1 BOX	07/05/2010	12/31/2019
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	12/31/2019

Labeler - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture(51645-269)

Revised: 12/2019

Document Id: 994f716f-25e8-7007-e053-2995a90a308e

34390-5

Set id: e37237f4-20a0-4599-84c8-d96c62062861

Version: 4

Effective Time: 20191209