FAD Backache and Muscle Relief
First Aid Direct Backache and Muscle Relief by
Drug Labeling and Warnings
First Aid Direct Backache and Muscle Relief by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, UltraTab Laboratories. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF- acetaminophen magnesium salicylate tablet
Cintas Corporation
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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FAD Backache and Muscle Relief
Purpose(s)
Active ingredients (in each tablet)
Acetaminophen 250 mg.........pain reliever/fever reducer
Magnesium salicylate 290mg (NSAID*)..pain reliever/fever reducer
Caffeine 50mg......................adjuvant/alertness aid
*Nonsteroidal anti-inflammatory drug
Active Ingredients
Active ingredients (in each tablet)
Acetaminophen 250mg…………………………………….pain reliever/fever reducer
Magnesium Salicylate 290mg (NSAID*)………………….pain reliever/fever reducer
Caffeine 50mg……………………………………………..adjuvant/alertness aid
Inactive Ingredients
hypromellose, maltodextrin, microcrystalline cellulose, povidone, polyethylene glycol, starch 1551, stearic acid, titanium dioxide
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: Allergy alert: Magnesium Salicylate may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may
include: ■ hives ■ asthma (wheezing) ■ facial swelling ■ shock ■ skin reddening ■ rash ■ blisters
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.
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.
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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do not use
■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to aspirin or salicylates ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ for children under 3 years of age unless directed by a doctor
Ask a doctor before use if ■ stomach bleeding warning applies to you
■ you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease ■ you are taking a diuretic ■ you have a history of stomach problems, such as heartburn
Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning of the blood) ■ diabetes ■ gout ■ arthritis
When using this product do not exceed recommended dose.
Stop use and ask 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
■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding, ask a health professional before use.
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 required for adults as well as children even if you do not notice any signs or symptoms.
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 required for adults as well as children even if you do not notice any signs or symptoms.
Directions
Adults and children 12 years and older: Take 1 to 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age: Ask a doctor
| FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF
acetaminophen magnesium salicylate tablet |
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| Labeler - Cintas Corporation (056481716) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| UltraTab Laboratories | 151051757 | manufacture(42961-111) | |
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