EXTRA STRENGTH ACETAMINOPHEN PM
-
acetaminophen and
diphenhydramine hydrochloride tablet, coated
McKesson
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- asthma
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urinating due to an enlargement of the prostate gland
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 a serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
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
- 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 this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.
Other information
- store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
- do not use if imprinted safety seal under cap is broken or missing
- **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered
trademark Tylenol® PM
Inactive ingredients
colloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 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
Product Labeling
**Compare to Tylenol® PM caplets active ingredients
EXTRA STRENGTH
Acetaminophen PM
Acetaminophen 500 mg, Diphenhydramine HCl 25 mg
Pain reliever /
Nighttime Sleep-Aid
50 CAPLETS
Do not use if imprinted safety seal under cap is broken or missing
| EXTRA STRENGTH ACETAMINOPHEN PM
acetaminophen, diphenhydramine hcl tablet, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 06/04/2012 | |
| Labeler - McKesson (177667227) |
Revised: 06/2012 McKesson