PAIN TERMINATOR: Package Insert and Label Information
PAIN TERMINATOR- aspirin, salicylamide and acetaminophen tablet
Provision Medical Products
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.
Uses:
temporarily relieves minor aches and pains
associated with: • backache • toothache • colds • headaches • muscular aches • menstrual cramps • minor arthritis pain
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.
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:
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 acetaminophen and aspirin or other pain
relievers/fever reducers. Acetaminophen and aspirin may
cause liver damage and 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 acetaminophen
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.
Directions:
Adults and children 12 years of age and older take 2 tablets
every 4 hours for pain as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years consult a doctor.
Inactive Ingredients:
FD&C yellow #6, magnesium stearate,
microcrystalline cellulose, povidone,
starch, and stearic acid.
ACTIVE INGREDIENT-ACETAMINOPHEN 110 MG, ASPIRIN 162 MG,CAFFEINE 32.4MG, SALICYLAMIDE 152 MG
PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT
| PAIN TERMINATOR aspirin, acetaminophen, caffeine, salicylamide tablet | |||||||||||||||||||||||||
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| Labeler — Provision Medical Products (036936831) |
| Registrant — Provision Medical Products (036936831) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Ultraseal Corporation | 085752004 | pack (69103-2507) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ULTRAtab Laboratories, Inc. | 151051757 | manufacture (69103-2507) | |
Revised: 01/2023 Provision Medical Products
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