Label: ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER tablet, chewable
- NDC Code(s): 51662-1356-1
- Packager: HF Acquisition Co LLC, DBA HealthFirst
- This is a repackaged label.
- Source NDC Code(s): 0904-6794
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 17, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT [IN EACH TABLET]
- PURPOSE
- USES
-
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 directedDo not use
if you are allergic to aspirin or any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctorAsk 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 have asthma
you are taking a diureticAsk a doctor or pharmacist before use if you are
taking a prescription drug for
gout
diabetes
arthritisStop 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
pain gets worse or lasts more than 10 days
fever get worse or lasts more than 3 days
redness or swelling is present
ringing in the ears or loss of hearing occurs
any new symptoms occurThese could be signs of a serious condition
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 accidental overdose, get medical help or contact a Poison Control Center right away.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER
aspirin low dose chewable orange pain reliever tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51662-1356(NDC:0904-6794) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code PH034 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51662-1356-1 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/27/2018 Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305) Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305) Establishment Name Address ID/FEI Business Operations HF Acquisition Co LLC, DBA HealthFirst 045657305 repack(51662-1356)