Pain Relief Pm Nightime Sleep Aid Recall
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Questions & Answers
Side Effects & Adverse Reactions
hildren under 12 years of age:
Do not give to children under 12 years of age. Liver Warning: This
product contains acetaminophen. Severe liver damage may occur if
you take: • more than 2 tablets in 24 hours • with other drugs
containing acetaminophen (prescription or nonprescription). Ask a
doctor or pharmacist before using with other drugs if you are not
sure. • 3 or more alcoholic drinks every day while using this product
Caution: This product will cause drowsiness. • do not drive a motor
vehicle or operate machinery after use. • avoid alchoholic
beverages while taking this product • do not take this product if you
are taking sedatives or tranquilizers, without first consulting your
doctor • if sleeplessness persists continuously for more than 2
weeks, consult your doctor. Insomnia may be a symptom of serious
underlying medical illness. Do not use: • more than the
recommended dose • do not take this product unless directed by a
doctor, if you have a breathing problem such as emphysema or
chronic bronchitis, or if you have glaucoma or difficulty in urination
due to enlargement of the prostate glandwith any other product containing
acetaminophen this will provide more than the
recommended dose (overdose) of acetaminophen
and could cause serious health concerns. • with any
other product containing diphenhydramine, even one
used on the skin • for more than 10 days for pain unless
directed by a doctor • for more than 3 days for fever unless
directed by a doctor. • when using this product do not exceed
recommended dose. Stop use and ask a doctor if:
• symptoms do not improve within 7 days or are accompanied by
a fever • pain or fever persists or gets worse • new symptoms
occur • redness or swelling is present • nervousness, dizziness or
sleeplessness occur Ask a doctor before use if you have:
• heart disease • high blood pressure • thyroid disease • diabetes
• difficulty in urination due to enlargement of the prostate gland
overdose, get medical help or contact a Poison Control Center
right away. Prompt medical attention is critical for adults as well as
for children even if you do not notice any signs or symptoms
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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: Temporarily relieves: • occasional headaches with minor
aches and pains • for relief of occasional sleeplessness Temporarily
relieves itchy eyes and runny nose associated with: • common
allergies • hay fever Warnings:
There is currently no drug history available for this drug.
There are no additional details available for this product.