EFFERVESCENT PAIN RELIEF FAST RELIEF FAST RELIEF- aspirin, citric acid anhydrous, and sodium bicarbonate tablet, effervescent 
Major Pharmaceuticals

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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Effervescent Pain Relief
Fast Relief

Drug Facts

Active ingredients (in each effervescent tablet)Purpose

 Aspirin 325 mg (NSAID)*

 Pain reliever

 Citric acid 1000 mg

 Antacid

 Sodium bicarbonate (heat-treated) 1916 mg

 Antacid

*non-steroidal anti-inflammatory drug

Uses

for the 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 should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy allert

Aspirin may cause a severe allergic reaction which may include:

•
hives
•
facial swelling
•
asthma (wheezing)
•
shock

Alcohol warning

if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Do not use

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

Ask a doctor before use if you have

•
been placed on a sodium restricted diet
•
asthma
•
ulcers
•
bleeding problems
•
stomach problems that last or come back, such as heartburn, upset stomach or pain

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 do not exceed the recommended dosage

Stop use and ask a doctor if

•
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 loss of hearing occurs

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

•
completely dissolve tablets in 4 ounces of water before taking

 Adults and children 12 years and over

 2 tablets every 4 hours
Do not exceed 8 tablets in 24 hours

 60 years and older

 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 564 mg
•
store at room temperature, protect from excessive heat
•
in water, this tablet contains prinipally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

none

Questions or comments?

Call 800.616.2471

DISTRIBUTED BY
MAJOR PHARMACEUTICALS
Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

Compare to Active
Ingredients in
Alka-Seltzer®*

MAJOR

EFFERVESCENT
PainRelief
FAST RELIEF

Relieves:

•
Heartburn
•
Acid Indigestion
•
Sour Stomach
with Headache
•
Body Aches and Pains

36 EFFERVESCENT TABLETS

Effervescent PainRelief
EFFERVESCENT PAIN RELIEF FAST RELIEF  FAST RELIEF
aspirin, citric acid anhydrous, and sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7948
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (Circular, flat faced, beveled edge, uncoated tablet) Size25mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7948-7336 in 1 BOX04/26/199606/17/2015
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/26/199606/17/2015
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-7948)

Revised: 7/2018
Document Id: 6f51494d-d3b6-45ab-884f-8b1c729cbea9
Set id: 27374ea7-8e0b-4764-b630-f4388663f9c8
Version: 3
Effective Time: 20180724
 
Major Pharmaceuticals