Tenalif Children

Manufacturer
OPMX LLC | GADAL Laboratories, Inc
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:18

Label at a glance#

ProductTenalif Children
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves these common cold/flu symptoms: sinus congestion & pressure minor aches & pains nasal congestion cough due to minor throat & bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter tsp = teaspoonful Age Dose Children 6 to under 12 years of age 10 mL or 2 tsp provided every 4 hours Children under 6 years of age do not use

Storage and handling

each 10 mL contains sodium 10 mg Store between 20-25°C (68-77°F) do not refrigerate keep carton for complete Drug facts

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL = 2 teaspoonful)Purpose
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan HBr 13.33 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal descongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold/flu symptoms:

  • sinus congestion & pressure
  • minor aches & pains
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver Warning:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

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.
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough sush as smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sodium restricted diet

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than recommended dose (overdose) may cause liver damaage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • tsp = teaspoonful
AgeDose
Children 6 to under 12 years of age10 mL or 2 tsp provided every 4 hours
Children under 6 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains
  • sodium 10 mg
  • Store between 20-25°C (68-77°F)
  • do not refrigerate
  • keep carton for complete Drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera, citric acid, disodium EDTA, FD&C red no. 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol, purified water, sodium benzoate, sorbitol 70%, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 616-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-070-06

Tenalif Children

6 fl oz (177 mL)

Tenalif ChildrenTenalif Children

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SolutionPSN2
1790651acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY2
1790651acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY2
1790651APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-070-06Tenalif Children177 mL in 1 BOTTLE, PLASTICSYRUP1772
69729-070-06Tenalif Children1 in 1 CARTONSYRUP12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-070TENALIF CHILDREN (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [OPMX LLC]2Current NDC, 2 package rows20241206_05cd9513-1a42-e990-e063-6294a90a57df.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-07069729-070-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
ndc (package): 69729-070-06
ndc (product): 69729-070
ndc11 (package): 69729007006
spl id: 2860afb9-3da9-5f80-e063-6394a90ab76b
spl set id: 05cd9513-1a42-e990-e063-6294a90a57df

Reported adverse events (FAERS/openFDA)#

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