Label: ALKA-SELTZER ORIGINAL- aspirin, citric acid, sodium bicarbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 53666-218-12, 53666-218-13, 53666-218-14 - Packager: SALIMEX, S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated July 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Do not use
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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) ● shockStomach 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 - Ask a doctor before use if
- Active ingredients (in each tablet)
- Uses
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
● an allergic reaction occurs. Seek medical help right away.
● 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
● symptoms get worse or last more than 10 days
● redness or swelling is present
● ringing in the ears or a loss of hearing occurs
● new symptoms occur - Questions or comments?
- If pregnant or breast-feeding,
- Keep out of reach of children
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Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
adults and children
12 years and over
2 tablets every 4
hours, or as
directed by a doctor
do not exceed 8
tablets in 24 hours
adults 60 years
and over
2 tablets every 4
hours, or as
directed by a doctor
do not exceed 4
tablets in 24 hours
children under
12 years
consult a doctor
- Other information
- Inactive ingredients
- Front and Back
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER ORIGINAL
aspirin, citric acid, sodium bicarbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53666-218 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score no score Shape ROUND Size 14mm Flavor Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53666-218-14 150 in 1 BOX 10/03/2017 1 NDC:53666-218-13 6 in 1 BOX 1 NDC:53666-218-12 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 not final part343 10/03/2017 Labeler - SALIMEX, S.A. (589201581) Registrant - SALIMEX, S.A. (589201581) Establishment Name Address ID/FEI Business Operations Bayer de México, S.A. de C.V. 588165709 manufacture(53666-218) Establishment Name Address ID/FEI Business Operations Salimex, S.A. 589201581 relabel(53666-218)