HISTENOL FORTE II- phenylephrine hcl, acetaminophen, guaifenesin tablet

Histenol Forte II by

Drug Labeling and Warnings

Histenol Forte II by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultra Seal Corporation, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Pain reliever, Expectorant,Nasal Decongestant

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Directions:

adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours

children under 12 years: ask a doctor

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional  
before use

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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	06/12/2012
1	NDC: 35418-111-68	50 in 1 CARTON
1	NDC: 35418-111-02	2 in 1 PACKET; Type 0: Not a Combination Product

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)