NDC | 69168-393-02, 69168-393-24, 69168-393-50, 69168-393-99 |
Set ID | 423a8445-964c-4cdb-889a-f391ca5253e7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Allegiant Health |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredients (in each caplet)
- Purpose
- Uses
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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 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
- 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 if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
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.
- You may report side effects to 1-888-952-0050
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen 500 mg and diphenhydramine hcl 25 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-393 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color blue Score no score Shape CAPSULE Size 16mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-393-02 150 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2014 2 NDC:69168-393-24 1 in 1 CARTON 12/23/2014 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69168-393-50 1 in 1 CARTON 12/23/2014 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69168-393-99 365 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2014 5 NDC:69168-393-26 1 in 1 CARTON 12/15/2021 5 20 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 not final part343 12/23/2014 Labeler - Allegiant Health (079501930)