- Active Ingredient
- Purpose
- Uses
-
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
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Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not use
- with any other drug containing acetaminophen (prescription or not prescription). 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
- With other products containing diphenhydramine, even one used on skin.
ask a doctor before use if you have
- liver disease
- asthma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- galucoma
ask your doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedative or tranquilizers.
When using this product
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery, this product will cause drowsiness
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.
- Keep out of reach of children.
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Directions
- do not exceed recommended dose
- 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Other Information
-
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF PM
acetaminophen pm tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-011 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-011-04 24 in 1 BOTTLE 1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/05/2012 Labeler - Velocity Pharma (962198409)