MEDIQUE MEDI SELTZER- aspirin, citric acid, sodium bicarbonate tablet, effervescent

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
Available from:
Unifirst First Aid Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever /fever reducer Antacid Antacid For the temporary relief of - heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains - upset stomach with headache from overindulgence in food or drink - headache, body aches, and pain alone
Authorization status:
OTC monograph final
Authorization number:
47682-135-20, 47682-135-24, 47682-135-60

MEDIQUE MEDI SELTZER- aspirin, citric acid, sodium bicarbonate tablet, effervescent

Unifirst First Aid Corporation

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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Medique Medi Seltzer

Drug Facts

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325mg

Citric Acid

Sodium bicarbonate (heat-treated) 1916mg

*nonsteriodal anti-inflammatory drug

Purpose

Pain reliever /fever reducer

Antacid

Antacid

Uses

For the temporary relief of

heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and

pains

upset stomach with headache from overindulgence in food or drink

headache, body aches, and pain alone

Warnings

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not

use this product. When using this product, if changes in behavior with nausea and vomiting occur,

consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious

illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you:

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,

or others)

have 3 or more alcohol drinks every day while using this product

take more or for a longer time than directed

Do not use

if you have ever had an allergic reaction to any other pain reliever/ fever reducer

if you are taking a prescription drug for gout, diabetes or arthritis

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you reached age 60 or older

you are on a sodium restricted diet

Ask a doctor or pharmacist before use if you are

taking any other drugs (prescription or non-prescription). Antacids may interact with certain drugs.

under a doctor's care for any serious condition

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

you feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

you have difficulty swallowing

ringing in the ears or loss of hearing occurs

redness or swelling is present in the painful area

any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to

use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because

it may cause problems in the unborn child or complications during delivery.

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

to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

Adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours. Do not

exceed 8 tablets in 24 hours or do not use the maximum dosage for more than 10 days.

Children under 12 years of age: do not give to children under 12 years of age.

60 years and older: do not exceed 4 tablets in 24 hours or do not use the maximum dosage for more

than 10 days.

Other information

each tablet contains: Sodium 524mg

read all product information before using

store at room temperature 59º-86º F (15º-30º C)

avoid excessive heat and humidity

tamper evident sealed packets

do not use any opened or torn packets

Inactive ingredients

none

Questions or comments?

1-800-634-7680

Medique Medi-Seltzer Label

Medique®

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See inside flap for more details

Medi-Seltzer

Effervescent Antacid/Pain Reliever

Pull to Open

This Package is for Households without Young Children.

Aches, Fever Aspirin (NSAID) 325 mg

Antacid Citric Acid 1000 mg Sodium Bicarbonate 1916mg

72 Tablets

(36 x 2)

Tamper Evident Unit Dose Packets

MEDIQUE MEDI SELTZER

aspirin, citric acid, sodium bicarbonate tablet, effervescent

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:476 8 2-135

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) (ANHYDROUS CITRIC ACID -

UNII:XF417D3PSL)

ANHYDROUS CITRIC

ACID

10 0 0 mg

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO) (BICARBONATE ION - UNII:HN1ZRA3Q20 )

SODIUM

BICARBONATE

19 16 mg

Product Characteristics

Color

white (white)

S core

no sco re

S hap e

ROUND (ROUND)

S iz e

25mm

Flavor

Imprint Code

L421

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:476 8 2-135-20

18 in 1 BOX

12/30 /20 0 8

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:476 8 2-135-24

36 in 1 BOX

12/30 /20 0 8

2

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:476 8 2-135-6 0

30 0 in 1 BOX

12/30 /20 0 8

3

2 in 1 PACKET; 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 rt343

12/30 /20 0 8

Unifirst First Aid Corporation

Labeler -

Unifirst First Aid Corporation (832947092)

Revised: 3/2020

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