FDA.reportPublic FDA data

ANTIGRIP Nighttime

Manufacturer
Pharmadel LLC
Effective date
2025-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:45:29

Label at a glance#

ProductANTIGRIP Nighttime
Active ingredientCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporary relieves common cold/flu symptoms: sore throat headache muscular aches backaches minor aches and pains runny nose sneezing itching of the nose or throat stuffy nose itchy, watery eyes due to hay fever or other upper respiratory allergies nasal & sinus congestion 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. glass 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. glass of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one pa...

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
Chlorpheniramine maleate 4 mg…………………………………………………………Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporary relieves common cold/flu symptoms:

  • sore throat
  • headache
  • muscular aches
  • backaches
  • minor aches and pains
  • runny nose
  • sneezing
  • itching of the nose or throat
  • stuffy nose
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • nasal & sinus congestion
  • 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 or 3 days for fever unless directed by a doctor
  • 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 doctor or pharmacist before taking this product
  • to sedate a child

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlargement of the prostate gland
  • taking sedatives or tranquilizers
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 occurs
  • a persistent cough or symptoms persists 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. glass 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. glass 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 13 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, 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55758-313-18

ANTIGRIP® Nighttime Cold & Cough

BoxBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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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 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-31355758-313-18

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

Source Document#

Source XML · Source PDF

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
4549c632-654f-64a4-e063-6294a90a7a2a852e5822-9bc0-06ed-e053-2a91aa0a5f1b2025-12-06WarningsExact identifier
spl id: 4549c632-654f-64a4-e063-6294a90a7a2a
spl set id: 852e5822-9bc0-06ed-e053-2a91aa0a5f1b

Reported adverse events (FAERS/openFDA)#

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