Active Ingredients
Acetaminophen 500 mg
Diphenhydramine HCI 25 mg
Extra Strength Pm Pain Medicine Tablet
FDA Label NDC 46122-799
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Extra Strength Pm Pain Medicine (NDC 46122-799). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain Reliever
Nighttime sleep aid
Uses
for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness
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.
Otc - Keep Out Of Reach Of Children
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.
Directions
• do not take more than directed (see overdose warning)
| Adults and Children 12 years and over | Take 2 caplets at bedtime.
Do not take more than 2 caplets of this product in 24 hours. |
| Children under 12 years of age | Do not use |
Other Information
• store at controlled room temperature 20-25 °C (68-77° F)
Inactive Ingredients
croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide
Questions Or Comments?
1-800-540-3765
Package Label
1 (224gnp)
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