FDA records indicate that there are no current recalls for this drug.
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Vanapain Pm Recall
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Questions & Answers
Side Effects & Adverse Reactions
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
- 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
- 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
- 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
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- take with food or milk if stomach upset occurs
- 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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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
- 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
- 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
- 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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- For relief of occasional sleeplessness when associated with minor aches and pains.
- Helps you fall asleep.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Vanapain Pm Manufacturers
-
Gm Pharmaceuticals, Inc.
Vanapain Pm | Dolgencorp, Inc. (dollar General & Rexall)
swallow tablet(s) with a glass of water swallow tablet(s) whole, do not crush, break, or chew adults and children 12 years of age and older take 2 tablets once or twice daily children 6 to under 12 years of age take 1 tablet once or twice daily children under 6 years of age ask a doctor
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