FDA.reportPublic FDA data

ANTIGRIP

Manufacturer
Pharmadel LLC
Effective date
2024-03-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:17

Label at a glance#

ProductANTIGRIP Nighttime
Active ingredientDOXYLAMINE SUCCINATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporary relieves common cold/flu symptoms: minor aches and pains sore throat headache nasal congestion runny nose itching of nose or throat stuffy nose cough due to minor throat and bronchial irritation and temporarily reduces fever

Dosage and administration

dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. sip while hot and consume the entire drink within 10-15 minutes Age Dose adults and children 12 years of age and over one (1) packet every 4 hours, take every 4 hours; do not exceed 6 packets in a 24 hours children under 12 years of age do not use

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)Purposes
Acetaminophen 325 mg…………………………………Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………...Cough suppressant

Doxylamine succinate 6.25 mg .....................................

Antihistamine

Phenylephrine HCI 5 mg…….…………………………..

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporary relieves common cold/flu symptoms:

  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • runny nose
  • itching of nose or throat
  • stuffy nose
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 packets in 24 hours, 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

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

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.
  • if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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

OTC - ASK DOCTOR SECTION

  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a cough that is accompanied by excessive phlegm (mucus)
  • have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness

Stop use and ask doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any 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

In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
  • sip while hot and consume the entire drink within 10-15 minutes
AgeDose
adults and children 12 years of age and overone (1) packet every 4 hours,

take every 4 hours; do not exceed 6 packets in a 24 hours

children under 12 years of agedo not use

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains: potassium 10 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 13 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • do not use if packet is punctured or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, aspartame, isopropyl alcohol, lemon ginger honey flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions & comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AD GHL PDPAD GHL PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2677914acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Powder for Oral SolutionPSN4
2677914acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Powder for Oral SolutionSCD4
2677914acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Powder for Oral SolutionSY4
2677914APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Powder for Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-382-01ANTIGRIPNighttime1 in 1 POUCHPOWDER, FOR SOLUTION14
55758-382-18ANTIGRIPNighttime18 in 1 CARTONPOWDER, FOR SOLUTION184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-382ANTIGRIP NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [PHARMADEL LLC]4Current NDC, 2 package rows20240328_12de30fd-95b6-f16d-e063-6294a90aeba2.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-38255758-382-01, 55758-382-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

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
ANTIGRIP NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLPharmadel LLC12de30fd-95b6-f16d-e063-6294a90aeba22024-03-27WarningsExact identifier
ndc (package): 55758-382-01
ndc (package): 55758-382-18
ndc (product): 55758-382
ndc11 (package): 55758038218
ndc11 (package): 55758038201
spl id: 14ac7b0a-30d9-e209-e063-6394a90a5c14
spl set id: 12de30fd-95b6-f16d-e063-6294a90aeba2

Reported adverse events (FAERS/openFDA)#

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