MUCUS RELIEF SINUS PRESSURE, PAIN AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydroc

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), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Meijer
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily relieves: headache nasal congestion minor aches and pains sinus congestion and pressure cough - headache - nasal congestion - minor aches and pains - sinus congestion and pressure - cough - promotes nasal and/or sinus drainage - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Authorization status:
OTC monograph final
Authorization number:
41250-979-02

MUCUS RELIEF SINUS PRESSURE, PAIN AND COUGH- acetaminophen, dextromethorphan

hydrobromide, guaifenesin, 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-1199-2019-0904

Drug Facts

Active ingredients (in each caplet)

Purpose

Acetaminophen 325 mg

Pain reliever

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

Us es

temporarily relieves:

headache

nasal congestion

minor aches and pains

sinus congestion and pressure

cough

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 12 caplets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks daily 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.

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.

Ask a doctor before use if you have

diabetes

liver disease

heart disease

high blood pressure

thyroid disease

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

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

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

When using this product do not use more than directed

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

Taking more than the recommended dose (overdose) may cause liver damage. 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)

do not take more than 12 caplets in any 24-hour period

adults and children 12 years of age and older: take 2 caplets every 4 hours

children under 12 years of age: do not use

Other information

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

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C

yellow #6 aluminum lake, magnesium stearate, maltodextrin, 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 41250-979-02

Compare to Mucinex® Sinus-Max® Pressure, Pain & Cough active ingredients†

Meijer®

mucus relief sinus pressure, pain & cough

Acetaminophen | Dextromethorphan HBr | Guaifenesin | Phenylephrine HCl

Pain Reliever, Cough Suppressant, Expectorant, Nasal Decongestant

Maximum Strength

Relief of: Sinus Pressure & Congestion;

Headache; Cough; Thins and Loosens Mucus

For Adults

20 CAPLETS

actual size

MUCUS RELIEF SINUS PRESSURE, PAIN AND COUGH

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -9 79

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

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 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, UNSPECIFIED (UNII: 2S78 30 E56 1)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

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

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

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

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

re d

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

AAA;116 5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:41250 -9 79 -0 2 2 in 1 CARTON

0 9 /0 1/20 19

1

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

Me ije r

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 9 /0 1/20 19

Labeler -

Meijer (006959555)

Revised: 9/2019

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