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Histenol Forte II

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg, ACETAMINOPHEN 325mg, GUAIFENESIN 100mg
Labeler: Zee Medical Inc
NDC Code: 35418-111

Drug Facts

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

HISTENOL FORTE II 
phenylephrine hcl, acetaminophen, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeZEE;HF2
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-111-67125 CARTON in 1 CARTON
1NDC:35418-111-6850 PACKET in 1 CARTON
1NDC:35418-111-022 TABLET 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/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture(35418-111)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(35418-111)

 
Zee Medical Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.