poly hist forte

SPL v6

SPL

SPL Set ID 8aa0015b-8fc1-7951-e053-2a95a90a8e72

Route

oral

Published

Effective Date 2019-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

doxylamine (10.5 mg) phenylephrine (10 mg)

Inactive Ingredients

fd&c blue no. 2 magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance

Imprint: Poly;216 Shape: capsule Color: blue Size: 14 mm Score: 2

Marketing Status

otc monograph drug active Since 2019-06-01

Purpose

Antihistamine

Description

Drug Facts

Medication Information

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

Purpose

Antihistamine

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.

Description

Drug Facts

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

Section 42229-5

Drug Facts

Active Ingredients

(in each tablet)

Doxylamine Succinate 10.5mg

Questions? Comments?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals, Inc.

Huntsville, AL Rev. 4/16

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.

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

Ask A Doctor Before Use If

you are taking sedatives or tranquilizers.

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.

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

Structured Label Content

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

Purpose

Antihistamine

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 (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 (Inactive ingredients)

FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients (Active ingredients)

(in each tablet)

Doxylamine Succinate 10.5mg

Questions? Comments?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals, Inc.

Huntsville, AL Rev. 4/16

Do Not Use This Product (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.

When Using This Product (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

Ask A Doctor Before Use If (Ask a doctor before use if)

you are taking sedatives or tranquilizers.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

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.

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "10.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "Purpose": "Antihistamine", "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.", "Active ingredients": "(in each tablet) Doxylamine Succinate 10.5mg", "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", "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.", "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", "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", "Ask a doctor before use if": "you are taking sedatives or tranquilizers.", "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.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:16.170128 · Updated: 2026-03-14T23:03:15.788850