Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL capsule
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 18, 2017
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- Active ingredients
- Liver warning
- Allergy alert
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
- Ask a doctor or pharmacist before use if you are
- When using this product
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.
- If pregnant or breast-feeding
- Keep out of the reach of children
- Overdose warning
- Other information
- Inactive ingredients
- Inactive ingredients
- Questions or comments?
- EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each Asprin Free Non Habit-Forming 100 CAPLETS+ (+ Capsule-Shaped Tablets)
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-990 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 CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) Product Characteristics Color blue Score no score Shape CAPSULE Size 18mm Flavor Imprint Code G651 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-990-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/17/2017 Labeler - FREDS, INC (005866116)