ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER tablet, chewable

ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER by

Drug Labeling and Warnings

ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT [IN EACH TABLET]

Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

for the temporary relief of minor aches and pains or as recommended by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

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
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

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
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 occur

These 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

drink a full glass of water with each dose

adults and children 12 years and over take 4 to 8 tablets every 4 hours not exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years consult a doctor

OTHER INFORMATION

store at room temperature (150-300C)
Tamper Evident: do not use if safety seal under cap is broken or missing

INACTIVE INGREDIENT

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

QUESTIONS

1-800-616-2471

DOSAGE & ADMINISTRATION

drink a full glass of water with each dose

adults and children 12 years and over take 4 to 8 tablets every 4 hours not exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years consult a doctor

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

for the temporary relief of minor aches and pains or as recommneded by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER 
aspirin low dose chewable orange pain reliever tablet, chewable

Product 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)