PAIN RELIEVER / LOW DOSE ASPIRIN- aspirin tablet, chewable

Pain Reliever / Low Dose Aspirin by

Drug Labeling and Warnings

Pain Reliever / Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC, PHARBEST PHARMACEUTICALS, INC.. 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 this product

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 alergic 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 alergic to aspirin or any other pain reliever/fever reducer
• this product for at least 7 days after tonsilectomy or oral surgery unless directed by a doctor
• if you have allergic reaction to this product or any of its ingredients

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

• 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
• allergic reaction occurs
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• any new symptoms occur
• 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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 to exceed 48 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

Other information

• Tamper Evident: Do not use if the safety seal under the cap is broken or missing
• Store at room temperature (15°-30°C) 59ºF- 86ºF
• Avoid excess heat and moisture

Inactive ingredients

Corn starch, dextrose monohydrate, FD&C yelow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

Questions or comments?

Adverse drug event call: (866) 562-2756 (Mon-Fri 8AM to 4PM EST)

Package Label Principal Display Panel

PHARMAMED

NDC: 84289-366-36

Manufactured in the U.S.A

Pain Reliever (NSAID) / Low Dose

ASPIRIN

Aspirin 81 mg

36 CHEWABLE

Aspirin regimen

Orange Flavored

*Compare to the active ingredient in BAYER Chewable Aspirin

INGREDIENTS AND APPEARANCE

PAIN RELIEVER / LOW DOSE ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-366(NDC:16103-366)
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
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	PH034
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-366-36	36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2024

Labeler - PHARMAMED USA INC (065607328)

Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
PHARBEST PHARMACEUTICALS, INC.		557054835	repack(84289-366)