HEB EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, citric acid, sodium bicarbonate tablet, effervescent

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

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Active ingredient:
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)
Available from:
H. E. Butt Grocery Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
(in each effervescent tablet) Anhydrous citric acid 1000 mg..............................................................Antacid Aspirin 500 mg (NSAID) *......................................................................Pain reliever Sodium bicarbonate (heat-treated) 1985 mg........................................Antacid *Nonsteroidal anti-inflammatory drug Uses for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ headache, body aches and pain alone ■ if you are allergic to aspirin or any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients ■ 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 have asthma ■ you have a sodium-restricte
Authorization status:
OTC monograph final
Authorization number:
37808-540-24

Read the complete document

HEB EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin,

citric acid, sodium bicarbonate tablet, effervescent

H. E. Butt Grocery Company

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.

----------

HEB Extra Strength Effervescent Antacid & Pain Relief

Active ingredients

(in each effervescent tablet)

Anhydrous citric acid 1000 mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Purpose

(in each effervescent tablet)

Anhydrous citric acid 1000 mg..............................................................Antacid

Aspirin 500 mg (NSAID)*......................................................................Pain reliever

Sodium bicarbonate (heat-treated) 1985 mg........................................Antacid

*Nonsteroidal anti-inflammatory drug

Uses

Uses for the temporary relief of

■ heartburn, acid indigestion and sour stomach when accompanied by 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

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 alcoholic drinks every day while using

this product ■ take more or for a longer time than directed

Do not use

■ if you are allergic to aspirin or any other pain reliever/fever reducer

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

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 have asthma

■ you have a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

■ presently taking a prescription drug. Antacids may interact with certain prescription

drugs.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or

arthritis

When using this product

When using this product do not take more than 8 tablets (adults) or 4 tablets (60

years and over) in a 24-hour period or use the maximum dosage for more than 2

weeks, except under the advice and supervision of a physician.

Stop use and ask a doctor if

Stop use and ask a doctor if you experience any of the following signs of stomach

bleeding

■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does

not get better

■ an allergic reaction occurs. Seek medical help right away.

■ pain lasts for more than 10 days or gets worse

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding

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

60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours

Children under 12 years: consult a doctor

Other information

each tablet contains: sodium 575 mg

■ store at room temperature (59º-86ºF)

Inactive ingredients:

flavor

Questions or comments?

1-888-228-6937

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF

aspirin, citric acid, sodium bicarbonate tablet, effervescent

Product Information

Product Type

HUMAN OTC DRUG

Item Code (Source)

NDC:37808-540

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Strength

Strength

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION -

UNII:HN1Z RA3Q20)

SODIUM

BICARBONATE

1985 mg

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

ASPIRIN

500 mg

ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID -

UNII:XF417D3PSL)

ANHYDROUS CITRIC

ACID

1000 mg

Inactive Ingredients

Ingredient Name

Strength

H. E. Butt Grocery Company

LEMON (UNII: 24RS0A988O)

Product Characteristics

Color

white

Score

no score

Shape

ROUND

Size

25mm

Flavor

Imprint Code

Contains

Packaging

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:37808-540-

12 in 1 CARTON

06/25/2020

1

2 in 1 POUCH; Type 0: Not a Combination

Product

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

OTC monograph final

part343

06/25/2020

Labeler -

H. E. Butt Grocery Company (007924756)

Revised: 4/2021

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