Drug Labeling and Warnings
Drug Details [pdf]
PAIN RELIEVER- acetaminophen, aspirin, salicylamide tablet
ADVANCED FIRST AID, 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.
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ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 100 MG, ASPIRIN 162 MG, SALICYLAMIDE 152 MG, CAFFEINE (ADJUVANT) 32.4 MG
Uses:
temporarily relieves minor aches and pains associated with:
headaches colds toothache minor arthritis pain muscular aches menstrual cramps backache
Warnings:
Reye's syndrome:
Children and teenagers should not use this medicine for chicken pox or flu symptoms before
a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if:
you take more than 8 tablets in 24 hours you take with other drugs containing acetaminophen (prescription
or non-prescription)
you have 3 or more alcoholic drinks every day while using this product
Stomach Bleeding Warning:
This product contains nonsteroidal anti-inflammatory drugs (NSAIDs)
which may cause stomach bleeding. The chance is higher if you:
have had stomach ulcers or bleeding
problems
take a blood thinning (anticoagulant) or steroid drug are age 60 or older have 3 or more
alcoholic drinks every day while using this product
take with other drugs containing an NSAID you take more
or for a longer time than directed
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 acetaminophen
Ask doctor before using if you have:
asthma stomach problems (such as heartburn, upset stomach or
stomach pain)
gastric ulcers bleeding problems
Ask a doctor or pharmacist before use if
you are taking a prescription drug for:
anticoagulation (thinning of blood) diabetes gout arthritis
When using this product do not exceed recommended dose.
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
If pregnant or breast-feeding baby,
ask a health professional
before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN
DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFIC-ALLY 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 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.
Adults and children 12 years of age and older:Take 2 tablets every 4 hours as
needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period.
Children under 12 years: Consult a doctor.
| PAIN RELIEVER
acetaminophen, aspirin, salicylamide tablet |
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| Labeler - ADVANCED FIRST AID, INC. (114477180) |
| Registrant - ADVANCED FIRST AID, INC. (114477180) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ULTRA SEAL CORPORATION | 085752004 | pack(67060-242) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ULTRA TAB LABORATORIES, INC. | 151051757 | manufacture(67060-242) | |