Label: TYLO NIGHT (ACETAMINOPHEN)- acetaminophen tablet, delayed release
- NDC Code(s): 49638-106-30
- Packager: America Medic & Science, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 2, 2024
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- Official Label (Printer Friendly)
- Tylo Night (Acetaminophen) 500 mg
- Active Ingredient
- Purpose
- Uses
- Warnings
-
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 DOCTOR
- ASK DOCTOR/PHARMACIST
- SPL UNCLASSIFIED SECTION
-
STOP USE
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
do not take more than directed (see overdose warning).
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
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
TYLO NIGHT (ACETAMINOPHEN)
acetaminophen tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-106 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 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE (UNII: FZ989GH94E) CROSPOVIDONE (UNII: 2S7830E561) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue Score no score Shape CAPSULE (CAPLET) Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49638-106-30 1 in 1 CARTON 07/06/2020 1 30 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 Drug M013 07/06/2020 Labeler - America Medic & Science, LLC (071065464) Registrant - America Medic & Science, LLC (071065464)