Label: CAREALL PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet
- NDC Code(s): 51824-108-50
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 23, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep Out of reach of Children
- Uses
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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 sever 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:
- 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 even 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
•do not drive a motor vehicle or operate machinery
•avoid alcoholic drinks
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 last for more than 10 days.
•fever gets worse or last for more than 3 days
•redness or swelling are present
•new symptoms occur. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL PAIN RELIEF PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) COPOVIDONE K25-31 (UNII: D9C330MD8B) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor Imprint Code AAA;1031 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-108-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/23/2024 Labeler - New World Imports, Inc (075372276)