CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY by

Drug Labeling and Warnings

CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients Purpose
(in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

PURPOSE

Purpose

Acetaminophen ……....…….... Pain reliever/fever reducer
Dextromethorphan HBr …....Cough suppressant
Guaifenesin ………….....…..…. Expectorant
Phenylephrine HCI …...……….Nasal decongestant

INDICATIONS & USAGE

Uses
temporarily relieves these common cold and flu symptoms:
nasal congestion stuffy nose minor aches and pains sore throat headache fever
cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include skinreddening blisters rash. If 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. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has
Iiver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product do not use more than directed (see Overdose warning)

Stop use and ask a doctor if
redness or swelling is present
nervousness, dizziness or sleeplessness occur
new symptoms occur
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
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

Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.

OVERDOSAGE

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. Quick 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 use more than directed (see Overdose warning)
shake well before using
do not use more than 5 doses in any 24-hour period
if needed, repeat dose every 4 hours while symptoms last
do not use more than 5 days unless directed by a doctor
use dosage cup

• Children 6 to under 12 years of age: 10 mL every 4 hours
• Children under 6 years of age: Do not use

OTHER SAFETY INFORMATION

Other information
each 10 mL contains: sodium 5 mg
store between IS-30°C (59-86°F)
do not refrigerate
dosage cup provided

INACTIVE INGREDIENT

Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate,
purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

QUESTIONS

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

Maximum Strength MAX COLD & SINUS

AP SAFE                       NDC: 76281-519-24

Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*

Children's

Cold, Cough 

& Sore Throat

Pain reliever/Fever Reducer
Cough Suppresant
Expectorant
Nasal decongestant

For Ages 6 to 12

Mixed Berry Flavor

4 FL OZ ( 118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

* This product is not manufactured or distributed by Reckitt

Benckiser Inc., distributor ofchildren's Mucinex® Cold,

Cough & Sore Throat liquid.

res

INGREDIENTS AND APPEARANCE

CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-519
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 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)
GLYCERIN (UNII: PDC6A3C0OX)
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: 76281-519-24	1 in 1 CARTON	01/30/2024
1		118 mL in 1 BOTTLE; 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	01/30/2024

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-519)