Adult Low Dose Aspirin: Package Insert and Label Information

ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release
PD-Rx Pharmaceuticals, Inc.

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.

Active Ingredient (in each tablet):

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product.

Reye’s syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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
  • asthma (wheezing)
  • facial swelling
  • 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • the 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

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 while symptoms persist. Do not to exceed 48 tablets in 24 hors or as directed by a physician
  • children under 12 years: consult a physician

Other information

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

Inactive ingredients: crosscarmellose Sodium, D&C yellow# 10 Lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.


Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Round yellow delayed release tablet imprinted with PH023 is supplied in:

Bottles of 35 NDC 72789-039-35

Bottles of 100 NDC 72789-039-01

Bottles of 120 NDC 72789-039-98

72789039 Label
(click image for full-size original)
ADULT LOW DOSE ASPIRIN
aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72789-039(NDC:16103-356)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow (YELLOW COLOR) Score no score
Shape ROUND (ROUND TABLET) Size 8mm
Flavor Imprint Code PH023
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-039-98 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:72789-039-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:72789-039-35 35 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 01/12/2007
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-039)

Revised: 12/2021 PD-Rx Pharmaceuticals, Inc.

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