Label: TYLO EXTRA (ACETAMINOPHEN)- acetaminophen tablet, delayed release
- NDC Code(s): 49638-112-30
- Packager: America Medic & Science, LLC
- 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 January 22, 2019
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- Tylo Extra 1000 mg
- Active Ingredient
- Do not use
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Overdose warning: Taking more than the recommended 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.
do not take more than directed (see overdose warning).
Adults and children 12 years and over:
- take 1 caplet every 6 to 8 hours
- Do not take more than 4 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?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
TYLO EXTRA (ACETAMINOPHEN)
acetaminophen tablet, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape capsule Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49638-112-30 1 in 1 CARTON 01/17/2019 1 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 01/17/2019 Labeler - America Medic & Science, LLC (071065464) Registrant - America Medic & Science, LLC (071065464) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc 037052099 manufacture(49638-112)