Label: MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable
- NDC Code(s): 72854-085-16
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 26, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
-
Uses
■ temporarily relieves these common cold and flu symptoms:
■ minor aches and pains
■ sore throat
■ headache
■ cough due to minor throat and bronchial irritation as may occur with
the common cold or inhaled irritants
■ runny nose■ sneezing
■ temporarily reduces fever
■ controls cough to help the user get to sleep -
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage
may occur if:
■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is
the maximum daily amount
■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is
the maximum daily amount
■ taken with other drugs containing acetaminophen
■ adult has 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
■ to make a child sleepy
■ with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
■ if the user is 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.Ask a doctor before use if you have
■ has liver disease
■ has a sodium-restricted diet
■ has glaucoma
■ has a breathing problem such as emphysema or chronic bronchitis
■ has difficulty in urination due to enlargement of the prostate gland
■ is a child with pain of arthritisAsk a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizersWhen using this product
■ do not use more than directed (see Overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ use caution when driving a motor vehicle or operating machineryStop use and ask a doctor if
■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
■ 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
If pregnant or breast-feeding, ask a health professional before use.
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. Prompt medical attention is critical for adults as
well as for children even if you do not notice any signs or symptoms. -
DOSAGE & ADMINISTRATION
Directions
■ do not take more than directed (see Overdose warning)
■ chew thoroughly before swallowing
■ dose every 4 hours or as directed by a doctoradults and children 12 years
of age and over4 chewable tablets every 4 hours, not to exceed
6 doses (24 chewable tablets) in any 24-hour periodchildren 6 to under 12 years
of age2 chewable tablets every 4 hours, not to exceed
5 doses (10 chewable tablets) in any 24-hour periodchildren under 6 years of age do not use - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU
acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-085 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 3.125 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 162.5 mg Inactive Ingredients Ingredient Name Strength MALIC ACID (UNII: 817L1N4CKP) CORN SYRUP (UNII: 9G5L16BK6N) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SODIUM CHLORIDE (UNII: 451W47IQ8X) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SUCROSE (UNII: C151H8M554) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) PECTIN (UNII: 89NA02M4RX) POTASSIUM SODIUM TARTRATE (UNII: QH257BPV3J) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color purple Score no score Shape ROUND Size 23mm Flavor BERRY (Mixed Berry) Imprint Code M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-085-16 16 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 06/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/01/2025 Labeler - RB Health (US) LLC (081049410)

