Otc - Purpose
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 194 mg | Pain reliever |
| Aspirin 227 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever |
| Caffeine 33 mg | Pain reliever aid |
Vanquish Tablet, Coated
FDA Label NDC 42364-0011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dse Healthcare Solutions, Llc for the product Vanquish (NDC 42364-0011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, other, do not use, ask a doctor before use if, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses temporarily relieves minor pain due to
- headache
- arthritis
- backache
- colds
- menstrual cramps
- muscle aches
Other
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.
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- blisters
- rash
- more than 8 caplets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do Not Use
- with any other drug 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 any other pain reliever/fever reducer
Ask A Doctor Before Use If
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
Stop Use And Ask A Doctor If
- an allergic reaction occurs. Seek medical help right away.
- 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
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than the recommended dose
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
Other Information
- save carton for full directions and warnings
- store at room temperature
Inactive Ingredients
Colloidal Silicon Dioxide, Corn Starch, Hypromellose, Maltodextrin, Microcrystalline Cellulose, Polydextrose, Povidone, Sodium Carboxymethyl Starch, Stearic Acid, Talc, Titanium Dioxide and Triglycerides
Each tablet contains 0.11 mg. of Sodium
Questions Or Comments?
Call: 1-800- 214-2379
www.vanquishheadacherelief.com
VANQUISH® is a registered trademark of SVADS Holdings SA
Distributed by DSE Healthcare Solutions, LLC
27070 Miles Rd, Suite A, Solon, OH 44139
Principal Display Panel
MADE IN USA
Do not use this product if printed safety seal under cap is torn or missing.
Effective Headache Relief
VANQUISH®
Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
100 Analgesic COATED CAPLETS
Distributed by DSE Healthcare Solutions, LLC
27070 Miles Rd, Suite A, Solon OH 44139
011-2201 L
EXPIRES 82-375210 11042-03-17
MADE IN USA
Effective Headache Relief
VANQUISH®
Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
100 Analgesic COATED CAPLETS
VANQUISH® is a registered trademark of SVADS Holdings SA
Distributed by DSE Healthcare Solutions, LLC
27070 Miles Rd, Suite A, Solon OH 44139
www.vanquishheadacherelief.com
EXPIRES
11043-03-17
011-2201 C
MADE IN USA
Do not use this product if printed safety seal under cap is torn or missing.
Effective Headache Relief
VANQUISH®
Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
120 Analgesic COATED CAPLETS
Distributed by DSE Healthcare Solutions, LLC
27070 Miles Rd, Suite A, Solon OH 44139
011-2202 L
EXPIRES 82-375210 11044-03-17
MADE IN USA
- BONUS - 20% MORE!
Effective Headache Relief
VANQUISH®
Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
120 Analgesic COATED CAPLETS
VANQUISH® is a registered trademark of SVADS Holdings SA
Distributed by DSE Healthcare Solutions, LLC
27070 Miles Rd, Suite A, Solon OH 44139
www.vanquishheadacherelief.com
EXPIRES
11045-03-17
011-2202 C
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