EXTRA STRENGTH TYLENOL PM
-
acetaminophen and
diphenhydramine hydrochloride tablet, coated
Lil' Drug Store Products, Inc.
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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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
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
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.
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)
| adults and children 12 years and over |
|
| 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 |
Other information
- store between 20-25°C (68-77°F)
- do not use if carton or pouch is open or torn
- see bottom panel for lot number and expiration date
Inactive ingredients
carnauba wax, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide
Repackaged and distributed by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE, Cedar Rapids, IA 52402
1-877-507-6516 (M-F 8AM-4:30PM CST)
www.lildrugstore.com
PRINCIPAL DISPLAY PANEL - 4 caplet Carton
See New Warnings Information & Directions
Extra Strength
TYLENOL®
PM
Pain Reliever
Nighttime Sleep Aid
Acetaminophen,
Diphenhydramine HCl
Non-habit
forming
Caplets
4 CAPLETS
Lil'
Drug Store
| EXTRA STRENGTH TYLENOL PM
acetaminophen and diphenhydramine hydrochloride 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 | 05/10/2010 | 12/19/2012 |
| Labeler - Lil' Drug Store Products, Inc. (093103646) |
Revised: 12/2012 Lil' Drug Store Products, Inc.