Label: FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF- acetaminophen magnesium salicylate tablet
- NDC Code(s): 42961-111-81, 42961-111-83
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 24, 2021
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- Active Ingredients
- Inactive Ingredients
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
- Other Information
- First Aid Direct (FAD) Backache and Muscle Relief
INGREDIENTS AND APPEARANCE
FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF
acetaminophen magnesium salicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 290 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 50 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-111-83 80 in 1 BOX 03/25/2021 1 NDC:42961-111-81 2 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/25/2021 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations UltraTab Laboratories 151051757 manufacture(42961-111)