Tylo Night (Acetaminophen)

Manufacturer
America Medic & Science, LLC
Effective date
2024-02-02
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:11:52

Label at a glance#

ProductTylo Night (Acetaminophen)
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

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.

Label contents#

Full prescribing information#

Tylo Night (Acetaminophen)500 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Night time sleep aid

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Liver warning: This product contains Acetaminophen. Severe liver damage may occur 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 using this product.

Do not use

OTC - DO NOT USE SECTION

  • 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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask your doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

SPL UNCLASSIFIED SECTION

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • store between 20-25°C (68-77°F)
  • do not use if neck wrap is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carnauba Wax, FD&C blue No.1 al lake, FD&C blue No.2 al lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Croscarmellose Sodium, Povidone, Crosspovidone, Pregelatinized Starch, Stearic Acid, Titanium Dioxide, Triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-855-470-6722

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-106-302024-02-02C16284748780-10191ceaa-62c5-198a-e063-dbdaa90aec3eTylo Night (Acetaminophen) 500 mg
49638-106-302023-07-28C16284748780-10191ceaa-62c5-198a-e063-dbdaa90aec3eTylo Night (Acetaminophen) 500 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-106TYLO NIGHT (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]8Legacy NDC20240203_709babea-c67a-479b-b47e-18e935de5518.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49638-10649638-106-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b96363a-0e2e-0d1f-e063-6294a90abb30709babea-c67a-479b-b47e-18e935de55182026-02-24WarningsExact identifier
spl set id: 709babea-c67a-479b-b47e-18e935de5518

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.