ADVANCED PAIN RELIEVER by ADVANCED FIRST AID, INC. / ULTRA SEAL CORPORATION / ULTRA TAB LABORATORIES, INC.
ADVANCED PAIN RELIEVER by
Drug Labeling and Warnings
ADVANCED PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ADVANCED PAIN RELIEVER- acetaminophen, aspirin, caffeine 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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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 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:
Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert:
Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if you take:
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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 with other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
have 3 or more alcoholic drinks every day while using this product
you take more or for a longer time than directed
Caffeine Warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medcations, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use:
with any other product containing acetaminophen (prescription or nonprescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns
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
Ask doctor before using if you have:
stomach problems (such as heartburn, upset stomach or stomach pain)
stomach bleeding warning applies to you
gastric ulcers
bleeding problems
you have athma, high blood pressure, heart disease, liver disease, or kidney disease
you are taking a diuretic
Ask a doctor or pharmacist before use if
you are taking a prescription drug for: anticoagulation (thinning of blood) diabetes gout arthritis
under a doctor's care for any serious condition
taking any other drug
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
you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.
an allerginc reaction occurs
Seek medical help right away.
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 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.
Directions:
Adults and children 12 years of age and older:Take 2 tablets every 6 hours as needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.
Children under 12 years: Ask a doctor.
| ADVANCED PAIN RELIEVER
acetaminophen, aspirin, caffeine 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(67060-117) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ULTRA TAB LABORATORIES, INC. | 151051757 | manufacture(67060-117) | |