NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Nighttime Cold and Flu by
Drug Labeling and Warnings
Nighttime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each 20 mL)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine even one used on the skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash, or headache that lasts These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24 hours period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- dose as follows or as directed by a doctor
- adults and children 12 years and older :
- 20 mL every 4 hours while symptoms last
- children under 12 years of age do not use
- Other information
- Inactive ingredients
-
Principal Display Panel
Compare to the active ingredients of Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu*
Maximum Strength
Fast Acting
Night Time Cold & Flu
Multi-Symptom Relief
Acetaminophen
Diphenhydramine HCI
Phenylephrine HCI
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
- For ages 12 years and over
FL OZ (mL)
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
- Product Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, diphenhydramine hci, phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55910-460 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYL GALLATE (UNII: 8D4SNN7V92) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55910-460-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/31/2018 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.