Histenol Forte II description, usages, side effects, indications, overdosage, supplying and lots more!

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Histenol Forte II

Zee Medical Inc
Ultra Seal Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient (in each tablet)  Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mg

Purpose

Purpose-Pain reliever, Expectorant,Nasal Decongestant

Uses

Uses ■ temporarily relieves the following cold and flu symptoms:
■ nasal and sinus congestion ■ headache ■ minor aches and pains
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings:Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
¦ more than 12 tablets in 24 hours, which is the maximum daily amount ¦ with other drugs containing acetaminophen
¦ 3 or more alcoholic drinks every day while using this product
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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
¦ heart disease ¦ high blood pressure ¦ diabetes ¦ liver disease ¦ thyroid disease
¦ trouble urinating due to an enlarged prostate gland
¦ cough that occurs with too much phlegm (mucus)
¦ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
¦ you get nervous, dizzy or sleepless
¦ pain, nasal congestion or cough gets worse or lasts more than 7 days
¦ cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
¦ redness or swelling is present in the painful area ¦ any new symptoms appear

If pregnant or breast-feeding baby, 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 right away.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive ingredients
FDC red 40, maltodextrin, microcrystalline cellulose, povidone, silica, sodium starch glycolate, starch, stearic acid

MM1Histenol Forte II1

Histenol Forte II

Phenylephrine HCl, Acetaminophen, Guaifenesin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35418-111
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
maltodextrin
cellulose, microcrystalline
POVIDONE K29/32
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
pink (rose pink) 12 mm ZEE;HF2 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-111-02 2 in 1 PACKET
2 NDC:35418-111-68 50 in 1 CARTON
3 NDC:35418-111-67 125 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-06-12


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