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
Drug Label Information
Updated November 18, 2024
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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?
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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 Drug M012 03/28/2019 Labeler - Pharmadel LLC (030129680)
