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

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Children's Cold, Cough & Sore Throat mixed Berry Flavor

Drug Facts

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

Purpose

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

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

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 productdo 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. In case of overdose, get
medical help or contact a Poison Control Center right
away.

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.

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

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

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

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? 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.

519 4 Oz

519 4 Oz Botl

res

CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-519-241 in 1 CARTON01/30/2024
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/30/2024
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-519)

Revised: 2/2024
Document Id: 2f25ce5a-4e46-4e77-be6d-041a502a5049
Set id: 5962a73e-72e4-493b-94a7-43bc6cf9c82f
Version: 2
Effective Time: 20240201
 
AptaPharma Inc.