ShopRite Childrens Multi Symptom Cold Relief

Manufacturer
Wakefern Food Corporation
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:06:19

Label at a glance#

ProductShopRite Childrens Multi Symptom Cold Relief
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves • minor aches and pains • headache • minor sore throat pain • runny nose • itchy nose or throat • sneezing • itchy, watery eyes due to hay fever • nasal and sinus congestion • cough due to minor throat and bronchial irritation as may occur with a cold • temporarily reduces fever

Dosage and administration

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Overdose warning) • shake well before using • may be given every 4-6 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor. • use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device. Age Dose children under 4 year...

Storage and handling

• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F). Protect from light. • close cap tightly

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
  • minor aches and pains
  • headache
  • minor sore throat pain
  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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:

  • 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

OTC - DO NOT USE SECTION

  • in a child under 4 years of age
  • if your child has ever had an allergic reaction to this product or any of its ingredients
  • 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.
  • to make a child sleepy

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • shake well before using
  • may be given every 4-6 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

Age

Dose

children under 4

years of age

do not use

children 4 to under 6

years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

10 mL

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F). Protect from light.
  • close cap tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-SHOPRITE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to: Active Ingredients in Children’s Triaminic® Multi-Symptom Fever & Cold

SEE NEW WARNINGS

Children’s

AGES 6-11 YEARS

MULTI-SYMPTOM COLD RELIEF

Oral Suspension

FEVER & SORE THROAT

Acetaminophen

STUFFY NOSE

Phenylephrine HCl

COUGH

Dextromethorphan HBr

SNEEZING & RUNNY NOSE

Chlorpheniramine Maleate

PAIN RELIEF

Fever Reducer – Pain Reliever

Cough Suppressant – Antihistamine

Nasal Decongestant

Grape flavor

4 FL OZ (118 mL)

ShopRite Multi-Symptom Cold Relief
ShopRite Multi-Symptom Cold Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB5052
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6X2
SORBITOLINACTIVE INGREDIENT506T60A25R2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41190-90341190-903-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 545 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RECTAL904 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
be855f47-eee8-4997-9f27-eef1b879f7270dafd054-1bae-424e-b9bd-0f0cb3cc9fd12020-12-02WarningsExact identifier
spl set id: 0dafd054-1bae-424e-b9bd-0f0cb3cc9fd1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.