FDA.reportPublic FDA data

ANTIGRIP Daytime

Manufacturer
Pharmadel LLC
Effective date
2025-12-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:45:30

Label at a glance#

ProductANTIGRIP Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For the temporary relief of the common cough and cold/flu symptoms: sore throat headache muscular aches backaches minor aches and pains nasal congestion due to hay fever other respiratory allergies sinus congestion and pressure cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

DO NOT EXCEED RECOMMENDED DOSE take every 4 hours; do not exceed 6 packets in a 24 hour period dissolve the contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one packet every 4...

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)Purposes
Acetaminophen 650 mg………………………………………………………………Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg……………………………………………………………Cough suppressant
Phenylephrine HCI 10 mg…….………………………………..……………………………Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of the common cough and cold/flu symptoms:

  • sore throat
  • headache
  • muscular aches
  • backaches
  • minor aches and pains
  • nasal congestion due to hay fever
  • other respiratory allergies
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • 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

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

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 7 days for pain and 3 days or fever, unless directed by a doctor
  • if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent of chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

Stop use and ask doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms persist for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. 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

  • DO NOT EXCEED RECOMMENDED DOSE
  • take every 4 hours; do not exceed 6 packets in a 24 hour period
  • dissolve the contents of one packet into 8 oz. of hot water and sip while hot; consume entire drink within 10-15 minutes
  • if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.
AgeDose
adults and children 12 years of age and overone packet every 4 hours
children under 12 years of agedo not use

Other information

SPL UNCLASSIFIED SECTION

  • each packet contains: sodium 26.73 mg, potassium 9.71 mg
  • phenylketonurics: contains phenylalanine 14 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • avoid excessive heat and moisture

TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, maltodextrin, silicone dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55758-314-18

ANTIGRIP® Daytime/Día

Cold & Cough/Gripe y Tos

Lemon/Limón

LABELLABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

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
55758-31455758-314-18

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
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
4549b549-8b9a-5fe8-e063-6394a90aca14853012b8-d3b7-78d3-e053-2a91aa0ab0f22025-12-06WarningsExact identifier
spl id: 4549b549-8b9a-5fe8-e063-6394a90aca14
spl set id: 853012b8-d3b7-78d3-e053-2a91aa0ab0f2

Reported adverse events (FAERS/openFDA)#

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