Panatuss PED

Manufacturer
Seyer Pharmatec, Inc.
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:00:33

Label at a glance#

ProductPanatuss PED
Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                         Purpose
(in each 5 mL teaspoonful)

Chlophedianol HCl 25 mg ...................... Cough Suppressant

Dexchlorpheniramine Maleate 2 mg ......... Antihistamine

Pseudoephedrine HCl 60 mg ................... Nasal Decongestant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold

  • calms the cough control center and relieves coughing
  • non narcotic cough suppressant for the temporary relief of cough
  • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies
  • temporarily relieves nasal congestion due to the common cold
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

WARNINGS SECTION

Warnings

When using this product

  • use only as directed by physician
  • may cause excitability especially in children
  • may cause marked drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

OTC - DO NOT USE SECTION


Do not use

  • 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
  • if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
  • if you are taking sedatives or tranquilizers, without first consulting your doctor
Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 6 hours, not to exceed 4 doses in 24 hours or as directed by a physician

Adults and Children 12 years of age and older
1 teaspoonful (5 mL)
Children 6 to under 12 years of age
1/2 teaspoonful (2.5 mL)
Children under 6 years of age
Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric acid, flavor, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?1-888-782-3585

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

panatusspedpanatussped

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11026-2775-42020-12-23C16284748780-19d75b9d1-0c24-f424-e053-dadaa90a57ceDrug Facts
11026-2775-42020-01-31C16284748780-19d75b9d1-0c24-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11026-2775-4ML - Milliliter11026-277586d48bc5-fe10-40f7-9cd9-680f37458df612013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998Y1
DEXCHLORPHENIRAMINE MALEATEACTIVE INGREDIENTB10YD955QW1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
CHLOPHEDIANOLACTIVE MOIETY42C50P12AP1
DEXCHLORPHENIRAMINEACTIVE MOIETY3Q9Q0B929N1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

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
11026-277511026-2775-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 434 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates

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
888a2078-444f-498c-bea5-641de87fd094e78c7e0c-2399-4e8a-9687-183b00e5b3332021-10-15WarningsExact identifier
spl set id: e78c7e0c-2399-4e8a-9687-183b00e5b333

Reported adverse events (FAERS/openFDA)#

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