Extra Strength Pain Reliever PM
Generic: ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Basic Information
Manufacturer
INGLES MARKETS, INC.
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
27fd288e-c07a-617f-e063-6394a90a17a4
Purpose
Purposes Pain Reliever Sleep aid
Indications & Usage
Uses for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness
Warnings
Warnings Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
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 • if you have ever had an allergic reaction to this product or any of its ingredients 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: In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
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 • if you have ever had an allergic reaction to this product or any of its ingredients 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: In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.