NDC | 55319-237-03, 55319-237-12 |
Set ID | 7b44e456-e9da-46ac-a805-0ffc0cab5992 |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar (FAMILY WELLNESS) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each gelcap)
- Purpose
- 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
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
Stop use and ask a doctor if
- sleeplessness persists continuosuly for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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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Inactive ingredients
croscarmellose sodium, D&C red #28, D&C yellow #10 edible ink, FD&C blue #1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, purified water, silicon dioxide, stearic acid, titanium dioxide, triacetin
- Questions or comments?
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Principal Display Panel
Compare to the active ingredients of TYLENOL® PM*
Extra Strength
Pain Reliever PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming
Rapid Release Gelcaps
Gelcaps
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®PM.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
VISIT FAMILY DOLLAR.COM
DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD, MATTHEWS, NC 28105 USA
- Product Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-237 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) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 20mm Flavor Imprint Code G3G3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-237-12 1 in 1 CARTON 07/31/2014 12/30/2022 1 120 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55319-237-03 1 in 1 BOX 07/31/2014 12/30/2022 2 300 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/31/2014 12/30/2022 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)