RxNorm Names
PAIN RELIEVER PM EXTRA STRENGTH
(acetaminophen, diphenhydramine hcl)
tablet
[Mckesson (Sunmark)]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fd0156eb-2374-4bda-b992-59590257b6c5| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 2 caplets in 24 hours, which is maximum daily amount
- 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 other products 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
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 (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)
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adults and children 12 years and over |
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children under 12 years |
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Inactive ingredients
colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*
*contains one or more of these ingredients
Principal Display Panel
Compare to TYLENOL® PM active ingredients**
Pain Reliever PM
extra strength
sleep aid for pain with sleeplessness
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| PAIN RELIEVER PM
EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet |
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| Labeler - Mckesson (Sunmark) (177667227) |
Review RxNorm Normal Forms