Active Ingredients
(in each tablet)
Doxylamine Succinate 10.5mg
(in each tablet)
Phenylephrine HCl 10 mg
Poly Hist Forte Tablet
FDA Label NDC 50991-626
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Poly Hist Forte (NDC 50991-626). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, do not use this product, ask a doctor before use if you have, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Nasal Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis)or other upper respiratory allergies:
- nasal congestion
- reduces swelling of nasal passages
- runny nose
- sneezing
- itching of nose or throat
- itchy, watery eyes
Do Not Use This Product
- 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.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask A Doctor Before Use If
you are taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast-Feeding,
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.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over | 1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours. |
| Children 6 to 12 years of age: | 1/2 tablet every 4 hours, not to
exceed 3 tablets in 24 hours. |
| Children 6 years
of age and younger: | Consult a physician. |
Other Information
Store at controlled room temperature between 15°-30°C (59°-86°F).
Supplied in a tight, light-resistant container with a child-resistant cap.
Poly Hist Forte Tablets are blue, caplet-shaped, scored tablets, debossed "Poly" bisect "216" on one side and plain on the other.
Inactive Ingredients
FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Questions? Comments?
Call 1-800-882-1041
Manufactured for:
Poly Pharmaceuticals, Inc.
Huntsville, AL Rev. 4/16
Principal Display Panel
NDC 50991-626-01
POLY HIST FORTE ®
TABLETS
Nasal Decongestant • Antihistamine
NEW FORMULA
Each tablet contains:
Doxylamine Succinate . . . 10.5 mg
Phenylephrine HCl . . . . . . 10 mg
100 Tablets
Back (Newfortelabelback)
Label (Newfortelabel)
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