ANTIGRIP NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl powder, for solution

ANTIGRIP by

Drug Labeling and Warnings

ANTIGRIP by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

Active Ingredients & Purposes

• 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

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

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

• 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

• 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

• taking the blood thinning drug warfarin

When using this product

• 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

• 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,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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

• 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

Other information

• 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

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

Questions & comments?

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

Dist by:

PHARMADEL LLC

New Castle, DE 19720

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIGRIP  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-382
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (Lemon - Ginger - Honey)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-382-18	18 in 1 CARTON	03/28/2024
1	NDC: 55758-382-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/28/2024

Labeler - Pharmadel LLC (030129680)