VANAPAIN PM- choline salicylate, diphenhydramine hydrochloride liquid
Vanapain PM by
Drug Labeling and Warnings
Vanapain PM by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, Inc., Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
- hives
- skin reddening
- rash
- facial swelling
- shock
- asthma (wheezing)
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 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
Do not use
- if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/fever reducer
- unless you have time for a full night's sleep
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- if you have sleeplessness without pain
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diurectic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have asthma
- you have glaucoma
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers, or any other sleep-aid
- under a doctor's care for any continuing medical illness
- taking a prescription drug for diabetes, gout or arthritis
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- take with food or milk if stomach upset occurs
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
- have stomach pain that does not get better
- vomit blood
- have bloody or black stools
- symptoms do not improve
- pain gets worse or lasts more than 10 days
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- ringing in the ears or loss of hearing occurs
- redness or swelling is present in the painful area
- fever gets worse or lasts more than 3 days
- any new symptoms appear
- Directions
- Other Information
- Inactive Ingredients
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 57mL Bottle Label
ONE SHOT
PM RELIEF
GLUTEN FREE
SUGAR FREE
TWIST TO OPEN
Do not use if neckband is broken or missing
NDC # 58809-444-60
VanaPain ®PM
CHOLINE SALICYLATE 870mg (NSAID) - Pain Reliver
DIPHENHYDRAMINE HCl 50mg - Nighttime Sleep Aid
Nighttime Pain Relief
Nighttime Sleep Aid
- Headache
- Backache
- Muscle Aches
- Minor Arthritis Pain
- Menstrual Cramps
Works Liquid Fast!
NON-HABIT FORMING
Great Tasting Strawberry Flavor!
NET WT: 1.93 OZ. (57ML)
Directions:
- Do not take more than directed.
- Adults and children 12 years of age and over: take 1 (57mL) bottle at bedtime.
- Do not take more than 1 (57mL) bottles in 24 hours.
- Children under 12 years of age: Do not use.
PATENT PENDING
-
INGREDIENTS AND APPEARANCE
VANAPAIN PM
choline salicylate, diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58809-444 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE 870 mg in 57 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 57 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58809-444-60 57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/28/2013 Labeler - GM Pharmaceuticals, Inc. (793000860) Establishment Name Address ID/FEI Business Operations Woodfield Pharmaceutical, LLC 079398730 manufacture(58809-444)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.