ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Labeler
- Cispharma, Inc
- Label updated
- 2011-03-28
- Retrieved
- 2026-09-07
- Active ingredients
- See original label
Drug Facts
Active ingredient (in each caplet)
Acetaminophen ..............................500 mg
Diphenhydramine HCl ......................25 mg
성분·작용
Pain Reliver
Nighttime Sleep Aid
Uses
temporarily 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 everyday while using this product
Label information
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 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
Label information
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
Label information
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin; ■ taking sedatives or tranquilizers
Label information
When using this product■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery.
Label information
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.
효능·용도
Indicated for pain relief and night time sleep aid.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of reach of children.
Overdasage Warnings;
Taking more than the recommended dose (overdose) may liver damage. In case of overdose, get medical help or contact poison control center right away. 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)
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adults and children 12 years and over |
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children under 12 years |
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Other Information
- store between 20°- 25°C (68°- 77°F)
- do not use if the box is opened
Inactive Ingredients
Carnauba wax, FD&C blue # 1 al lake, FD&C blue # 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
Label information
*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® PM
Questions or Comments?
Call 1-866-383-9908
Manufactured by:
Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512
포장 표시
[Image in the official label — see DailyMed source]
DailyMed Set ID: bbaaa8bb-d389-4ce2-ad82-d805ec281f72 · Version 1
NDC: 52204-124