SINE OFF

Gemini Pharmaceuticals, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients (in each Caplet)
• Purpose
• SINE OFF Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • Keep out of reach of children
• Directions
• SINE OFF Other information
• Inactive ingredients
• Questions or comments?
• Package label Sine Off Maximum Strength

FULL PRESCRIBING INFORMATION

Active Ingredients (in each Caplet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Pain reliever

Nasal decongestant

SINE OFF 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

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 )

• 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.

• 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.
  

SINE OFF Other information

• Store at room temprature
• 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 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