COUGH AND SINUS PE- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Meijer
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache - sinus congestion and pressure - nasal congestion - cough - sore throat - minor aches and pains - headache - promotes nasal and sinus drainage - temporarily reduces fever
Authorization status:
OTC monograph final
Authorization number:
41250-372-02

COUGH AND SINUS PE- acetaminophen, dextromethorphan hydrobromide, 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-1172-2019-0903

Drug Facts

Active ingredients (in each caplet)

Purpose

Acetaminophen 325 mg

Pain reliever/fever reducer

Dextromethorphan HBr 10 mg

Cough suppressant

Phenylephrine HCl 5 mg

Nasal decongestant

Us es

temporarily relieves these common cold/flu symptoms:

sinus congestion and pressure

nasal congestion

cough

sore throat

minor aches and pains

headache

promotes nasal and sinus drainage

temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg

acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,

rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

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.

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur

pain, nasal congestion, or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs

or symptoms.

Directions

do not take more than directed (see overdose warning)

adults and children 12

years and over

take 2 caplets every 4 hours

do not take more than 10 caplets in 24 hours

children under 12

years

ask a doctor

Other information

store between 20-25°C (68-77°F) in a dry place

retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc,

titanium dioxide

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

NDC 41250-372-02

Compare to Sudafed PE® Pressure + Pain + Cough active ingredients†

Meijer®

NON-DROWSY

cough + sinus PE

Acetaminophen | Phenylephrine HCl | Dextromethorphan HBr

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant

Relief of: Sinus Headache & Sore Throat;

Sinus Pressure & Congestion; Cough

Pressure,

Pain & Cough

For Adults

24 CAPLETS

actual size

COUGH AND SINUS PE

acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -372

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

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

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

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

AAA;1172

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -372-0 2 2 in 1 CARTON

0 4/0 1/20 17

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

Me ije r

OTC mo no graph final

pa rt341

0 4/0 1/20 17

Labeler -

Meijer (006959555)

Revised: 9/2019

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