Meijer Extra Strength Pain Relief Pm Caplet Tablet
FDA Label NDC 79481-0149
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Meijer Extra Strength Pain Relief Pm Caplet (NDC 79481-0149). 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 drug facts, active ingredients (in each caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep aid
Uses
temporary relief of occasional headaches and minor aches and pains 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 •rashIf 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• trouble urinating due to an enlarged prostate gland •glaucoma
Ask a doctor or pharmacist before use if you are •taking the blood thinning drug warfarin •taking sedatives or tranquilizers
When using this product •drowsiness will occur •avoid alcoholic drinks •do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness •pain gets worse or lasts more than 10 days •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur These could 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.
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 | do not use |
Other Information
• store at room temperature 20°-25°C (68°-77°F)
• protect from light, heat and moisture
Inactive Ingredients
croscarmellose sodium, FD&C blue no.1 aluminum lake, FD&C blue no.2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, starch corn, talc, titanium dioxide
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Packaging
Image Description (79481 0149)
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