Childrens Plus Multi-Symptom Cold Grape by Rite Aid Corporation Drug Facts

Childrens Plus Multi-Symptom Cold Grape by

Drug Labeling and Warnings

Childrens Plus Multi-Symptom Cold Grape by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension 
Rite Aid Corporation

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.

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Drug Facts

Active Ingredients

Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCI 2.5 mg

Purposes

Acetaminophen...........................Pain reliever/fever reducer
Chlorpheniramine maleate..........Antihistamine
Dextromethorphan HBr..............Cough suppressant
Phenylephrine HCI......................Nasal decongestant

Uses

temporarily relieves the following cold/flu
symptoms: minor aches and pains cough
headache sore throat sneezing and runny nose
stuffy nose temporarily reduces fever

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
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
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.
with any other drug containing acetaminophen
(prescription or non-prescription). If you are not
sure whether a drug contains acetaminophen,
ask a doctor or pharmacist.

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
persistent or chronic cough such as occurs with
asthma cough that occurs with too much phlegm
(mucus) heart disease high blood pressure
thyroid disease diabetes glaucoma liver disease

Ask a doctor or pharmacist before use if the child is taking

sedatives or tranquilizers
the blood thinning drug warfarin

When using this product

do not exceed recommended dosage (see overdose warning)
may cause excitability, especially in children
marked drowsiness may occur sedatives and
tranquilizers may increase drowsiness

Stop use and ask a doctor if

new symptoms occur
fever gets worse or lasts for more than 3 days
redness or swelling is present
pain, nasal congestion or cough gets worse or
lasts for more than 5 days
nervousness, dizziness or sleeplessness occur
cough comes back or occurs with rash or headache
that lasts. These could be signs of a serious
condition

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
accidental overdose, seek professional assistance or
contact a Poison Control Center immediately. Quick
medical attention is critical even if you do not notice
any signs or symptoms.

Directions

do not exceed recommended dosage
(see overdose warning) shake well before using
find right dose on chart below. If possible, use
weight to dose; otherwise, use age
if needed, repeat dose every 4 hours while
symptoms last
do not give more than 5 times in 24 hours

Weight (lb)                    Age (yr)                    Dose (tsp or mL)
under 36                         under 4                      do not use
36-47                                4-5                             do not use unless directed by a doctor
48-95                                6-11                           2 tsps or 10 mL

Other Information

dosage cup provided
store at controlled room temperature

Inactive Ingredients

blue 1, carboxymethylcellulose sodium, cellulose,
citric acid, flavors, glycerin, purified water, red 33,
red 40, sodium benzoate, sorbitol, sucrose,
xanthan gum

Principal Display Panel

Rite Aid Pharmacy

Compare to active ingredients in Tylenol

Children's Plus Multi-Symptom Cold Grape

acetaminophen- pain reliever and fever reducer

chlorpheniramine maleate- antihistamine

dextromethorphan HBr- cough suppressant

Phenylephrine HCI -nasal decongestant

4 fl oz (118mL)

image of label


CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11822-1434
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11822-1434-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/200912/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/11/200912/30/2019
Labeler - Rite Aid Corporation (014578892)

Revised: 9/2019
 
Rite Aid Corporation