ANTIGRIP NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci powder, for solution 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ANTIGRIP Cold & Cough Nighttime

Drugs Facts

Active Ingredients & Purposes

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

Temporary relieves common cold/flu symptoms:

Warnings

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

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • 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

  • 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

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

When using this product

  • 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

  • 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,

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

AgeDose
adults and children 12 years of age and overone packet every 4 hours
children under 12 years of agedo not use

Other information

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

Inactive ingredients

acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, 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

PRINCIPAL DISPLAY PANEL

NDC 55758-313-18

ANTIGRIP® Nighttime Cold & Cough

Box

ANTIGRIP NIGHTTIME 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-313
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-313-1818 in 1 CARTON03/28/2019
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2019
Labeler - Pharmadel LLC (030129680)

Revised: 6/2020
Document Id: a7457170-bd84-bbfe-e053-2995a90aadda
Set id: 852e5822-9bc0-06ed-e053-2a91aa0a5f1b
Version: 2
Effective Time: 20200604
 
Pharmadel LLC