RxNorm Names
Review RxNorm Normal Forms
PAIN RELIEF PM EXTRA STRENGTH
(acetaminophen, diphenhydramine hcl)
capsule, coated
[Kroger Company]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0a5f11da-bb8f-4519-b569-2e322727e1b9| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
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 other 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.
Directions
- •
- do not take more than directed (see Liver 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 |
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
| PAIN RELIEF PM
EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule, coated |
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| Labeler - Kroger Company (006999528) |
