HISTENOL FORTE II - phenylephrine hydrochloride, acetaminophen and guaifenesin tablet 
Zee Medical Inc

Disclaimer: 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.

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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

MM1Histenol II 250 Box 1

HISTENOL FORTE II 
phenylephrine hcl, acetaminophen, guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-111
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color pink (rose pink) Score no score
Shape ROUND (ZEE;HF2) Size 12mm
Flavor Imprint Code ZEE;HF2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-111-67 125 in 1 CARTON
1 NDC:35418-111-68 50 in 1 CARTON
1 NDC:35418-111-02 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
Name Address ID/FEI Business Operations
Ultratab Laboratories, Inc. 151051757 manufacture(35418-111)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 repack(35418-111)

Revised: 11/2012
Document Id: 11e82391-4104-433d-b401-dd19c56bc33c
Set id: 248e8c14-4f50-46a4-8da4-d8edc47e5aac
Version: 1
Effective Time: 20121112
 
Zee Medical Inc