TEXACLEAR PM PAIN RELIEVER SLEEP AID
TEXACLEAR PM PAIN RELIEVER SLEEP AID by
Drug Labeling and Warnings
TEXACLEAR PM PAIN RELIEVER SLEEP AID by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
TEXACLEAR PM PAIN RELIEVER SLEEP AID- choline salicylate, diphenhydramine hcl liquid
GM Pharmaceuticals, INC
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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TEXACLEAR PM PAIN RELIEVER SLEEP AID
TexaClear PM Pain Reliever and Sleep Aid
(Choline Salicylate, Diphenhydramine HCl) Liquid
GM Pharmaceuticals, Inc.
Drug Facts
Active ingredients (per 30 mL)
Choline Salicylate (NSAID*) 870 mg
Diphenhydramine HCl 50 mg
*nonsteroidal anti-inflammatory drug
Uses
- for relief of occasional sleeplessness when associated with minor aches and pains
- helps you fall asleep
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
- shock
- rash
- asthma (wheezing)
- facial swelling
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 non-prescription 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
- with any other product containing diphenhydramine, even one used on skin
- unless you have time for a full night’s sleep
- if you have sleeplessness without pain
- in children under 12 years of age
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 diuretic
- 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 serious condition
- 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
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- sleeplessness persists continuously for more than 2 weeks; insomnia may be a symptom of a serious underlying medical illness.
Directions
- do not take more than directed.
- do not use in children under 12 years of age
- adults and children 12 years of age and over: take 30 mL at bedtime
- do not exceed 30 mL in 24 hours, unless directed by a doctor
- use enclosed dose cup
Other information
- each 30mL (2 TBSP) contains: Sodium 19 mg
- tamper evident: Do not use if foil seal under cap is broken or missing.
- read all product information before using
- store at 68° to 86°F (20° to 30°C)
- avoid excessive heat and humidity
| TEXACLEAR PM PAIN RELIEVER SLEEP AID
choline salicylate, diphenhydramine hcl liquid |
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| Labeler - GM Pharmaceuticals, INC (793000860) |