FDA records indicate that there are no current recalls for this drug.
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Extra Strength Night Time Pain Medicine Recall
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than directed • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product
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. • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age
Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin
• sedatives or tranquilizers
When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks
Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults / children even if you do not notice any signs / symptoms.
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 the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Extra Strength Night Time Pain Medicine Manufacturers
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Geri-care Pharmaceutical Corp
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