Indications & Usage
Uses:
temporarily relieves pains due to:•headache • minor pain of arthritis•muscular aches • temporarily reduces fever•common cold
Aspirin 5 Grain
FDA Label NDC 69103-2501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical Products for the product Aspirin 5 Grain (NDC 69103-2501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, otc - pregnancy or breast feeding, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, otc - active ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Pregnancy Or Breast Feeding
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
SPECIFICALLY DIRECTED TO DO SO BY
A DOCTOR, BECAUSE IT MAY CAUSE
PROBLEMS IN THE UNBORN CHILD OR
COMPLICATIONS DURING DELIVERY.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In
case of overdose, get medical help or
contact a Poison Control Center right
away. Prompt medical attention is
critical for adults as well as for children
even if you do not notice any signs or
symptoms.
Warnings
Warnings:
Reye's syndrome: Children and teenagers should not
use this medicine for chicken pox or -u symptoms
before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with
aspirin.
Alcohol Warning: If you consume 3 or more alcoholic
drinks every day, ask your doctor whether you should
take aspirin or other pain relievers/fever reducers.
Aspirin may cause stomach bleeding.
Do not use:
•
if you are allergic to aspirin
•
with any other pain reliever/fever reducer
•
if you have ever had an allergic reaction to any
other pain reliever/fever reducer
•
for pain for more than 10 days or for fever for
more than 3 days unless directed by a doctor
•
with any other product containing aspirin
Ask a doctor before using if you have:
•
asthma • gastric ulcers • bleeding problems
•
stomach problems (such as heartburn, upset stomach
or stomach pain)
Ask a doctor or pharmacist before use if you are
taking a prescription drug for:
• anticoagulation
(thinning of blood)
• diabetes • gout • arthritis
Stop use and ask a doctor if:
•
ringing in the ears or loss of hearing occurs
•
pain or fever persists or gets worse
•
new symptoms occur
•
redness or swelling is present
When using this product do not exceed
recommended dose
Dosage & Administration
Directions:
Adults and children 12 years of age and older take 2 tablets every 4 to 6hours as
needed, do not exceed 12 tablets in 24 hours, or as directed by
a doctor.
Children under 12 years consult a
doctor.
Do not use more than directed
Inactive Ingredient
Inactive Ingredients:
corn starch, povidone, silicon dioxide
and stearic acid.
Otc - Active Ingredient
ACTIVE INGREDIENT-ASPIRIN 325 MG
Otc - Purpose
PAIN RELIEVER/FEVER REDUCER
Package Label.Principal Display Panel
5 Grain Aspirin Box (Aspirin5grain)
5 Grain Aspirin Box (Aspirin5grain)
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