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hybrid CF

Hybrid-Rx LLC

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient


Active Ingredients (in each caplet)



Purpose

Purposes
Pain reliever/Fever Reducer
Antihistamine
Nasal Decongestant


Directions

Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

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Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

Warnings

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

more than 8 caplets in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.  Acetaminophen may cause liver damage.

Do Not Use

  • if you are now taking a 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 
  • with any other product containing any of the above active ingredients.
  • with any other drug containing acetaminophen (prescription or nonprescription).
  • Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers.

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase the drowsiness
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • redness of swelling is present
  • new symptoms occur
  • symptoms get worse or last for more than 7 days
  • fever gets worse or lasts more than 3 days

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Hybrid CF

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hybrid CF

hybrid CF

APAP 500 mg Phenylephrine HCL 5 mg Chlorpheniramine maleate 2 mg TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49804-101(NDC:62959-116)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (15 CPS)
triacetin
povidone
STEARIC ACID
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
yellow 17 mm PAC CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:49804-101-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-02-03


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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