1171-car-2024-0614
093199be-e92a-6f60-e063-6294a90a8533
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other Information
- store between 20-25ºC (68-77ºF)
- retain carton for complete product information
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
Description
Drug Facts
Principal Display Panel
CAREone®
NDC 72476-171-03
Compare to the actrive ingredients in Tylenol® PM Extra Strength†
Extra Strength
ACETAMINOPHEN PM
Acetaminophen - Pain Reliever
Diphenhydramine HCl - Nighttime Sleep Aid
For Adults
Actual Size
80 GELCAPS
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Section 50566-9
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
Section 50567-7
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Section 50568-5
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Section 50569-3
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
Section 50570-1
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
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1
| Active ingredients (in each gelcap) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep-aid |
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.
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
Overdose Warning
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.
Structured Label Content
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other Information (Other information)
- store between 20-25ºC (68-77ºF)
- retain carton for complete product information
Inactive Ingredients (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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
CAREone®
NDC 72476-171-03
Compare to the actrive ingredients in Tylenol® PM Extra Strength†
Extra Strength
ACETAMINOPHEN PM
Acetaminophen - Pain Reliever
Diphenhydramine HCl - Nighttime Sleep Aid
For Adults
Actual Size
80 GELCAPS
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1 (55105-1)
| Active ingredients (in each gelcap) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep-aid |
Allergy Alert (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.
Liver Warning (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
Overdose Warning (Overdose warning)
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.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:10.255936 · Updated: 2026-03-14T23:03:04.544899