CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE- childrens tylenol plus multi-symptom cold suspension

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 P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Children's Plus Multi-Symtpom Cold Grape

Acetaminophen Fever and sore throat

Chlorpheniramine maleate Runny nose and sneezing

Dextromethorphan HBr Cough

Phenylephrine HCI stuffy nose

For ages 6 to 11

Oral suspension

4 fl oz 118mL

INGREDIENTS AND APPEARANCE

CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
childrens tylenol plus multi-symptom cold suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-1434
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-1434-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/2009	12/30/2021

Labeler - P & L Development, LLC (101896231)