Active Ingredients
Acetaminophen 500 mg
Diphenhydramine HCI 25 mg
Extra Strength Night Time Pain Medicine Tablet
FDA Label NDC 57896-224
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Extra Strength Night Time Pain Medicine (NDC 57896-224). 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
Sleep aid
Uses
for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness
Warnings
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.
Otc - Keep Out Of Reach Of Children
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.
Directions
• do not exceed recommended dose
| Adults and Children 12 years and over | Take 2 caplets at bedtime if needed, or as directed by a doctor. |
| Children under 12 years | Do not use. |
Other Information
• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.
• store at room temperature
Inactive Ingredients
cellulose, croscarmellose sodium, FD and C blue no.1, hypromellose, PEG, stearic acid, titanium dioxide. May also contain silica, sodium starch glycolate.
Package Label
57896-224-05
Health star the sensible choice for price and health
Extra Strength
pain relief and sleep aid
night time pain medicine
acetaminophen 500 mg
Diphenhydramine HCl 25mg
100 caplets
compare to the active ingredients in tylenol pm
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