Family Wellness 44-235-Delisted
Acetaminophen PM by
Drug Labeling and Warnings
Acetaminophen PM by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hcl tablet, film coated
Family Dollar Services 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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Family Wellness 44-235-Delisted
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
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 product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- difficulty in urination due to enlargement of the 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
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- drowsiness will occur
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.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide
Principal Display Panel
NDC: 55319-235-15
FAMILY
wellness™
COMPARE TO THE ACTIVE INGREDIENTS
OF EXTRA STRENGTH TYLENOL® PM*
100% SATISFACTION
GUARANTEED
OR YOUR MONEY BACK
Extra Strength
Acetaminophen PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever, Nighttime Sleep-Aid
50 Caplets
ACTUAL SIZE
TAMPER EVIDENT: 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 Extra Strength Tylenol® PM.
50844 REV0615C23515
DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE ROAD
MATTHEWS, NC 28105 USA
Not 100% satisfied?
Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
Family Wellness 44-235
| ACETAMINOPHEN PM
EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet, film coated |
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| Labeler - Family Dollar Services Inc (024472631) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(55319-235) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(55319-235) | |