Indications and uses
Acetaminophen 160mg Soft Chews is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.
Acetaminophen
- Manufacturer
- Alexso, Inc
- Effective date
- 2020-02-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:40:14
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
Do not take more than directed (see overdose warning) Adults and children 12 years and over: take 4 soft chews every 4 to 6 hours while symptoms last or as directed by a physician chew each soft chew thoroughly before swallowing do not take more than 20 soft chews in 24 hours do not take for more than 10 days unless directed by a physician Children 6 to 11 years: take 2 soft chews every 4 to 6 hours while symptoms...
Storage and handling
each soft chew contains: sodium 7.44 mg . each soft chew contains : sugar 2g. store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Acetaminophen 160 mg Soft Chews
Alexso, Inc.
----------------
Acetaminophen 160 mg Soft Chews
DRUG FACTS
ACTIVE INGREDIENT
Acetaminophen 160mg
PURPOSE
Pain reliever/fever reducer
USES
Acetaminophen 160mg Soft Chews is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 10 doses in 24 hours
- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
- adults has 3 or more alcoholic drinks every day while 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.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Take under the supervision of a physician if you have liver disease, taking a blood thinning drug called warfarin, or have a history of high blood pressure or diabetes.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
If pregnant or breast-feeding, consult a physician or health professional before use.
KEEP OUT OF REACH OF CHILDREN
Overdose warning: 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.
DIRECTIONS
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- take 4 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
- chew each soft chew thoroughly before swallowing
- do not take more than 20 soft chews in 24 hours
- do not take for more than 10 days unless directed by a physician
Children 6 to 11 years:
- take 2 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
- chew each soft chew thoroughly before swallowing
- do not take more than 10 soft chews in 24 hours
- do not take for more than 5 days unless directed by a physician
Children under 6 years: ask a physician
OTHER INFORMATION
- each soft chew contains: sodium 7.44 mg.
- each soft chew contains: sugar 2g.
- store in a cool dry place between 20-25°C (68-77°F).
Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive ingredients:
hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.
HOW SUPPLIED
Acetaminphen 160mg Soft Chews is supplied in the following dosage form:
Fourteen (14) Soft Chews per container
Made in USA
Manufactured for:
Alexso, Inc.
2317 Cotner Ave
Los Angeles, CA 90064
NDC: 50488-4160-1
Size: 14 Soft Chews
PRINCIPAL DISPLAY PANEL
Acetaminophen 160 mg Soft Chews
14 Orange Flavored Gummies
Chewy Gummy Bites
NDC:50488-4160-1
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50488-4160-1 | 2023-04-25 | C162847 | 48780-1 | d6a99b39-38a4-a426-e053-dadaa90af4c2 | Acetaminophen 160 mg Chewable Gels |
| 50488-4160-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-38a4-a426-e053-dadaa90af4c2 | Acetaminophen 160 mg Chewable Gels |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-4160-1 | EA - Each | 50488-4160 | f024fcea-602f-49cf-bf35-9109bde7f89e | 1 | 2020-02-13 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- HYDROXYPROPYL BETADEX
- CARRAGEENAN
- MALTITOL
- SUCROSE
- SODIUM CITRATE
- SODIUM CHLORIDE
- SUCRALOSE
- NEOTAME
- MALTODEXTRIN
- CORN SYRUP
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50488-4160 | 50488-4160-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYDROXYPROPYL BETADEX | 1I96OHX6EK | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| MALTITOL | D65DG142WK | IACT |
| SUCROSE | C151H8M554 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| NEOTAME | VJ597D52EX | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7982e5f7-3bd6-4ce3-9dbb-995c94c53021 | 482b2128-2255-40f6-9436-60d42ad22b5e | 2023-04-28 | Warnings | 482b2128-2255-40f6-9436-60d42ad22b5e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.