Label: BEST CHOICE EFFERVESCENT ANTACID PAIN RELIEF- aspirin, citric acid, sodium bicarbonate tablet, effervescent
- NDC Code(s): 63941-421-12
- Packager: Valu Merchandisers Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated December 3, 2020
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- Active ingredients
Anhydrous citric acid 1000 mg.....................................................Antacid
Aspirin 325 mg (NSAID)*.............................................................Pain reliever
Sodium bicarbonate (heat-treated) 1916 mg...............................Antacid
*Nonsteroidal anti-inflammatory drug
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
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if you are
- When using this product
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 breastfeeding
- Keep out of reach of children.
- In case of overdose
■ 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 yrs 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
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL. PRINCIIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BEST CHOICE EFFERVESCENT ANTACID PAIN RELIEF
aspirin, citric acid, sodium bicarbonate tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-421 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code L421 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-421-12 6 in 1 CARTON 10/29/2020 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 10/29/2020 Labeler - Valu Merchandisers Company (868703513)