Your browser does not support JavaScript! SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

SINE OFF SINUS/COLD MEDICINE (acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride) tablet, film coated
[Gemini Pharmaceuticals, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients (in each caplet)

Acetaminophen 500mg

Chlorpheniramine maleate 2mg

Phenylephrine HCl 5mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • headache
  • 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

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
  • 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 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

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 temperature
  • 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, 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 1-888-876-6898

Package label Sine Off Maximum Strength

See the New Warning Information

Strong, Fast Relief!

SINE®

OFF

SINUS/COLD MEDICINE

  • Relieves Sinus Headache
  • Pain
  • Pressure
  • Congestion
  • Runny Nose
  • Sneezing
  • Itchy, Watery eyes
Each Caplet Contains:
Acetaminophen 500mg.............Pain Reliever
Chlorpheniramine maleate 2mg....Antihistamine
Phenylephrine HCl 5mg............Nasal decongestant

24 CAPLETS
Sine off Sinus Cold Medicine 24 Count Label


SINE OFF  SINUS/COLD MEDICINE
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51645-291
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULE (Capsule Shaped Tablet) Size17mm
FlavorImprint Code Sine;Off;PE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-291-121 in 1 BOX
112 in 1 BLISTER PACK
2NDC:51645-291-242 in 1 BOX
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/05/2010
Labeler - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc.055942270manufacture

Revised: 7/2010
 
Gemini Pharmaceuticals, Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services