Extra Strength Night Time Pain Medicine
Acetaminophen, Diphenhydramine HCl · Tablet · Oral
Active ingredient
Active Ingredients Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Purpose
Purposes Pain Reliever Sleep aid
Uses
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.
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
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
Other information
• store at controlled room temperature 20-25 °C (68-77° F)
Inactive ingredients
Inactive ingredients croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide
Questions?
Questions or comments? 1-800-540-3765
Label text from the FDA structured product label by Geri-Care Pharmaceutical Corp (revised May 21, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Diphenhydramine Hydrochloride in 1 product
Extra Strength Night Time Pain Medicine NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 57896-224 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet | Geri-Care Pharmaceutical Corp | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Extra Strength Night Time Pain Medicine used for?
Uses for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness
Who makes Extra Strength Night Time Pain Medicine?
Extra Strength Night Time Pain Medicine is listed by 1 labeler in the FDA NDC directory, including Geri-Care Pharmaceutical Corp.