ALLERGY AND SINUS PE- chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Meijer
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itchy, watery eyes nasal congestion itching of the nose or throat sinus congestion and pressure - runny nose - sneezing - itchy, watery eyes - nasal congestion - itching of the nose or throat - sinus congestion and pressure
Authorization status:
OTC monograph final
Authorization number:
41250-233-02

ALLERGY AND SINUS PE- chlorpheniramine maleate and phenylephrine hydrochloride tablet,

coated

Meijer

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.

----------

MEI-1133-2019-0903

Drug Facts

Active ingredients (in each tablet)

Purpose

Chlorpheniramine maleate 4 mg

Antihistamine

Phenylephrine HCl 10 mg

Nasal decongestant

Us es

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory

allergies:

runny nose

sneezing

itchy, watery eyes

nasal congestion

itching of the nose or throat

sinus congestion and pressure

Warnings

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.

Ask a doctor before use if you have

high blood pressure

heart disease

thyroid disease

diabetes

glaucoma

trouble urinating due to an enlarged prostate gland

a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

excitability may occur, especially in children

be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs

symptoms do not improve within 7 days or occur with 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 (1-800-222-1222).

Directions

adults and children 12 years and over: take 1 tablet every 4 hours; do not take more than 6 tablets in

24 hours

children under 12 years: do not use this product in children under 12 years of age

Other information

store at 20°-25°C (68°-77°F)

retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, dibasic dicalcium phosphate dihydrate, hypromellose, magnesium stearate,

microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

NDC 41250-233-02

Meijer®

MAXIMUM STRENGTH

allergy + sinus PE

Phenylephrine HCl | Chlorpheniramine Maleate

Nasal Decongestant, Antihistamine

Relief of: Sinus Pressure & Congestion;

Sneezing; Itchy Eyes & Runny Nose

Pressure,

Congestion & Allergy

For Adults

24 TABLETS

actual size

ALLERGY AND SINUS PE

ALLERGY AND SINUS PE

chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -233

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

4 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

STARCH, PREGELATINIZED CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

T127

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -233-0 2 2 in 1 CARTON

0 7/0 1/20 11

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 7/0 1/20 11

Labeler -

Meijer (006959555)

Me ije r

Revised: 9/2019

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