Label: ANTIGRIP NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci powder, for solution
- NDC Code(s): 55758-313-18
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 4, 2020
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- Drugs Facts
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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:
- 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
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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
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
- 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.
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Directions
- 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 packet every 4 hours children under 12 years of age do not use - Other information
- Inactive ingredients
- Questions & comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIGRIP NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-313-18 18 in 1 CARTON 03/28/2019 1 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 final part341 03/28/2019 Labeler - Pharmadel LLC (030129680)
