Label: MAXIMUM STRENGTH NIGHTTIME COLD AND FLU- acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-933-06 - Packager: Wal-Mart Stores,Inc.,
- 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 January 19, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 6 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions .Symptoms may include:
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- Skin reddening
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- Blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other drug containing diphenhydramine, even one used on the skin
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- 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
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
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- 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
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- you are taking the blood thinning drug warfarin
you are taking sedatives or tranquilizers
When using this product
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- do not use more than directed
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain, nasal congestion, or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
cough comes back, or occurs with fever, 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) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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Directions
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- do not take more than directed (see Overdose warning)
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- do not take more than 6 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- mL= milliliter
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- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL -
NDC# 49035-933-06
Compare to Mucinex® Fast-Max® Maximum Strength Severe Cold & Flu Active Ingredients*
Maximum Strength‡
Night TimeCold & Flu
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Acetaminophen Pain Reliever/Fever Reducer
Diphenhydramine HCl Antihistamine/Cough Suppressant
Phenylephrine HCl Nasal Deongestant - Multi- Symptom Relief
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- Relieves Ache, Fever and Sore Throat
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- Controls Cough
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- Relieves Nasal Congestion
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- Relieves Runny Nose & Sneezing
For Ages 12+
6 FL OZ (180 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Mucinex® Fast- Max® Maximum Strength Nighttime Cold & flu.
Tamper evident: do not use if printed seal under cap is broken or missing.
‡Maximum Strength per 4 hour dose.
Distributed by: Walmart Inc.,
Bentonville, AR 72716
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
acetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-933 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-933-06 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/02/2018 Labeler - Wal-Mart Stores,Inc., (051957769)
