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   

Uses

Temporarily relieves minor aches and pains associated with:

  • Muscular aches
  • 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: 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

Other Information

■ do not use if packet is torn, cut or opened ■ store at room temperature ■ avoid excessive heat and humidity
Questions? 1-800-327-2704
80 Tablets/2 Tablets per Packet

First Aid Direct (FAD) Backache and Muscle Relief

label-01

FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF 
acetaminophen magnesium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-111-8380 in 1 BOX03/25/2021
1NDC: 42961-111-812 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/25/202112/30/2022
Labeler - Cintas Corporation (056481716)
Establishment
NameAddressID/FEIBusiness Operations
UltraTab Laboratories151051757manufacture(42961-111)

Revised: 12/2022
 

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