Label: HISTENOL FORTE II - phenylephrine hydrochloride, acetaminophen and guaifenesin tablet
- NDC Code(s): 35418-111-02, 35418-111-67, 35418-111-68
- Packager: Zee Medical Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active Ingredient (in each tablet) Acetaminophen 325 mg, Phenylephrine HCL-5 mg, Guaifenesin-100 mgClose
Purpose-Pain reliever, Expectorant,Nasal DecongestantClose
- INDICATIONS & USAGE
Uses ■ temporarily relieves the following cold and flu symptoms:Close
■ 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 Close
Warnings:Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takeClose
¦ 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 professionalClose
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN. In case of overdose,Close
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
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 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)