Your browser does not support JavaScript! HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]
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HISTENOL FORTE II (phenylephrine hcl, acetaminophen, guaifenesin) tablet
[Zee Medical 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 Ingredient (in each tablet)  Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mg

Purpose-Pain reliever, Expectorant,Nasal Decongestant

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

Directions ¦ adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours ¦ children under 12 years: ask a doctor

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 II 250 Box 1

HISTENOL FORTE II 
phenylephrine hcl, acetaminophen, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (rose pink) Scoreno score
ShapeROUND (ZEE;HF2) Size12mm
FlavorImprint Code ZEE;HF2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-111-67125 in 1 CARTON
1NDC:35418-111-6850 in 1 CARTON
1NDC:35418-111-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-111)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(35418-111)

Revised: 11/2012
 
Zee Medical Inc

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