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SINE OFF MAXIMUM STRENGTH

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Gemini Pharmaceuticals, Inc.
NDC Code: 51645-269

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.

Drug Facts

Active Ingredients (in each Caplet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Pain reliever

Nasal decongestant

Uses
  • For 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

Warnings

Liver Warning:

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
  • 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: 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.

Directions
  • do not take more than directed (see overdose warning)
Adults and children 12 years and older:
  • 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.
Children under 12 years:
  • 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 temprature
  • avoid excessive heat and humidity
  • Retain carton for complete product information
Tamper evident: Do not use if sealed blister units are broken or damaged.

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 or comments?

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

Package label Sine Off Maximum Strength

See the New Warning Information

SINE®

OFF

Non-Drowsy Relief of

  • Sinus Headache
  • Pain
  • Pressure
  • Congestion
Each Caplet Contains:
Acetaminophen 500mg.............Pain Reliever
Phenylephrine HCl 5mg............Nasal decongestant

12 CAPLETS
SINE OFF  MAXIMUM STRENGTH
acetaminophen, phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-269
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (Capsule Shaped Tablet) Size17mm
FlavorImprint CodeSine;Off;PE
Contains    
Packaging
#Item CodePackage Description
1NDC:51645-269-121 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET, COATED (TABLET) in 1 BLISTER PACK
2NDC:51645-269-662 BLISTER PACK (BLISTER PACK) in 1 BOX
212 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2010
Labeler - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc.055942270manufacture

Revised: 07/2010
 
Gemini Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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