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

51645-269 SineOff Jul 2018

SINE OFF  MAXIMUM STRENGTH
acetaminophen, phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-269
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeCAPSULE (Capsule Shaped Tablet) Size17mm
FlavorImprint Code Sine;Off;PE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-269-121 in 1 BOX07/05/201211/30/2017
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51645-269-662 in 1 BOX07/05/201012/31/2019
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/201012/31/2019
Labeler - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc.055942270manufacture(51645-269)

Revised: 12/2019
 
Gemini Pharmaceuticals, Inc.