Poly Hist Forte by Poly Pharmaceuticals, Inc. / TG United, Inc. Poly Hist Forte
Poly Hist Forte by
Drug Labeling and Warnings
Poly Hist Forte by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc., TG United, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
POLY HIST FORTE- doxylamine succinate and phenylephrine hydrochloride tablet
Poly Pharmaceuticals, 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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Poly Hist Forte
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
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
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.
Quitman, MS 39355 Rev. 9/13
PRINCIPAL DISPLAY PANEL
NDC: 50991-216-01
POLY HIST FORTE ®
TABLETS
Nasal Decongestant Antihistamine
NEW FORMULA
Each tablet contains:
Doxylamine Succinate . . . 7.5 mg
Phenylephrine HCl . . . . . . 10 mg
100 Tablets
| POLY HIST FORTE
doxylamine succinate and phenylephrine hydrochloride tablet |
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| Labeler - Poly Pharmaceuticals, Inc. (198449894) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TG United, Inc. | 172837085 | manufacture(50991-216) | |