![EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SPIRIT PHARMACEUTICAL LLC]](https://medic.hrt.org//dailymed/images/561c6387-969d-4c82-8623-87774dd2ae21/0902381_APAP_PM_100ct_CTN_1128116_R1.jpg)
| NDC | 68210-1000-1, 68210-1000-5 |
| Set ID | 561c6387-969d-4c82-8623-87774dd2ae21 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Spirit Pharmaceutical LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur with this product 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 you are 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 other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- in children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- breathing problems such as emphysema or chronic bronchitis
- trouble urinating due to an enlargement of the 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
- 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 a serious underlying medical illness
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Overdose warning
Taking more than the directed dose (overdose) may cause liver damage. 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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Directions
- do not take more than directed
(see Overdose warning)
adults and children 12 years of age and over: - take 2 caplets at bedtime or as directed by a doctor
- do not take more than 2 caplets in a 24 hour period
children under 12 years of age: - 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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ACETAMINOPHEN PM
acetaminophen and diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1000 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape OVAL Size 18mm Flavor Imprint Code S525 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-1000-5 1 in 1 CARTON 08/12/2016 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68210-1000-1 1 in 1 CARTON 08/12/2016 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:68210-1000-2 1 in 1 CARTON 02/12/2020 3 24 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 08/12/2016 Labeler - Spirit Pharmaceutical LLC (179621011) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture(68210-1000)
