CARE ONE PAIN RELIEF AND PAIN RELIEF PM- acetaminophen, diphenhydramine hcl
American Sales Company
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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American Sales Company Pain Relief and Pain Relief PM Drug Facts
Active ingredient (in each caplet) (For Pain Relief PM)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Uses (For Pain Relief)
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- temporarily relieves minor aches and pains due to:
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- the common cold
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- headache
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- backache
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- minor pain of arthritis
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- toothache
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- muscular aches
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- premenstrual and menstrual cramps
- •
- temporarily reduces fever
Uses (For Pain Relief PM)
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings (For Pain Relief)
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.
Warnings (For Pain Relief PM)
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 (For Pain Relief)
- •
- 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
Do not use (For Pain Relief PM)
- •
- 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.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have (For Pain Relief PM)
- •
- liver disease
- •
- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are (For Pain Relief)
taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are (for Pain Relief PM)
- •
- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
Stop use and ask a doctor if (For Pain Relief)
- •
- pain gets worse or lasts more than 10 days
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- redness or swelling is present
These could be signs of a serious condition.
Stop use and ask a doctor if (For Pain Relief PM)
- •
- 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 (For Pain Relief)
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- do not take more than directed (see overdose warning)
- •
- Adults and children 12 years and over:
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- take 2 caplets every 6 hours while symptoms last
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- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- •
- do not use for more than 10 days unless directed by a doctor
Children under 12 years: ask a doctor
Directions (For Pain Relief PM)
- •
- do not take more than directed (see overdose warning)
- •
- 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
Inactive ingredients (For Pain Relief)
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain one or more of these ingredients
Inactive ingredients (For Pain Relief PM)
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Principal Display Panel
Compare to the Active Ingredient in Extra Strength Tylenol® Caplets
Extra Strength
PAIN RELIEF
PAIN RELIEVER - FEVER REDUCER
Acetaminophen
For Adults
Actual Size
See New Warnings
100 CAPLETS 500 mg Each
VALUE PACK - DAY & NIGHT RELIEF
Compare to the Active Ingredients in Extra Strength Tylenol® PM Caplets
Extra Strength
PAIN RELIEF PM
PAIN RELIEVER - NIGHTTIME SLEEP-AID
Acetaminophen
Diphenhydramine HCl
Actual Size
For Adults
Non-Habit Forming
See New Warnings
100 CAPLETS
| CARE ONE PAIN RELIEF AND PAIN RELIEF PM
acetaminophen, diphenhydramine hcl kit |
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| Labeler - American Sales Company (809183973) |