Zee Painaid Back Relief Formula

Zee Painaid Back Relief Formula by

Drug Labeling and Warnings

Zee Painaid Back Relief Formula by is a Otc medication manufactured, distributed, or labeled by Cintas Corp, UltraTab Labratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZEE PAINAID BACK RELIEF FORMULA- magnesium salicyclate, acetaminophen, caffeine tablet 
Cintas Corp

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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Zee Painaid Back Relief Formula

Active ingredients (in each tablet)

Acetaminophen 250 mg
Caffine 50 mg
Magnesium salicylate 290 mg (NSAID*)
*nonsteroidal anti-inflammatory

Purpose

Pain reliever

Adjuvant

Pain reliever

Use temporarily relieves minor back pain

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: Magnesium salicylate may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a reaction occurs, stop use and seek medical help right away.

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 other drugs containing prescription or nonprescription NDAIDs (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 heart beat

Do not use

  • with any other drug 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 reliver/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 a doctor before use if you have:

  • stomach problems (such as heartburn, upset stomach or stomach pains)
  • stomach bleeding warning applies to you
  • gastric ulcers
  • bleeding problems
  • you have asthma, 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, or arthritis. When using this product do not exceed recommended dose. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

​Stop use and ask 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 allergic reaction occurs. Seek medical help right away.

​If pregnant or breast-feeding, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE MAGNESIUM SALICYLATE 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 COMPLICAITONS 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: take 2 tablets every 6 hours, not more than 8 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • ​each tablet contains:​ magnesium 24 mg
  • store at 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)
  • Tamper Evident. Do not use if packet is torn or open

Inactive ingredients​ hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Questions? 1-800-327-2704 Monday-Friday 8:00-5:00PM

For industrial use only. Not for retail sale./Solo para uso industrial. No apto venta al por menor.

Distributed by/Distribuido por ​ZEE Medical Distributors, LLC ​Mason, OH 45040

Principal Display Panel

Back Relief Formula

Acetaminophen/Magnesium Salicylate (NSAID)/Caffeine

Pain Reliever

See new warnings information

100 Tablets (2 Tablets per Packet)

Distributed by ZEE Medical Distributors, LLC Mason, OH 45040

PA_BRF

ZEE PAINAID BACK RELIEF FORMULA 
magnesium salicyclate, acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-027
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg  in 1 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 1 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-027-0150 in 1 BOX02/17/2022
11360 mg in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/17/202212/27/2022
Labeler - Cintas Corp (056481716)
Establishment
NameAddressID/FEIBusiness Operations
UltraTab Labratories151051757manufacture(42961-027)

Revised: 12/2022
 

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