Giltuss Childrens MultiSymptom Cold and Flu
- Manufacturer
- Giltuss Pharmaceutical Corp | Dextrum Laboratories Inc
- Effective date
- 2025-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 6.5 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Antihistamine
Cough Suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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:
- 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.
OTC - DO NOT USE SECTION
Do not use
- in a child under 4 years of age
- if your child is allergic to acetaminophen or any inactive ingredient in this product
- 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- to make your child sleepy
OTC - ASK DOCTOR SECTION
Ask a doctor or pharmacist before use if the child has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts such as occurs with asthma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
OTC - STOP USE SECTION
Stop use and ask a doctor if
- nervousness, dizzyness or sleeplessness
- 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 fever, rash or headache that lasts.
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- use enclosed dosing cup
- keep dosing cup for use with this product
- mL = milliliter
| children under 6 years of age | Do not use |
| children 6 to under 12 years of age | 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours |
| children 12 years and over | 10 mL every 4-6 hours, not to exceed 6 doses in 24 hours |
OTHER SAFETY INFORMATION
Other information
- store at room temperature 15° - 30°C (59° - 86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
INACTIVE INGREDIENT SECTION
Inactive ingredients
Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-787-848-9114,Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.
SPL UNCLASSIFIED SECTION
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children's
Giltuss® MULTI-SYMPTOM
COLD & FLU
ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT
Alcohol Free. Sodium Free. Sugar Free. Dye Free
- FEVER, HEADACHE AND BODY ACHES
- COUGH AND COLD
- STUFFY NOSE
- SNEEZING AND RUNNY NOSE
STRAWBERRY FLAVOR
4FL OZ (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2121065 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 6.5 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution | PSN | 6 |
| 2121065 | acetaminophen 65 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.3 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 6 |
| 2121065 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 6.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution | SY | 6 |
| 2121065 | APAP 65 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.3 MG/ML / Phenylephrine Hydrochloride 1 MG/ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58552-137-04 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-b8e6-a426-e053-dadaa90af4c2 | Giltuss Children's Multi-Symptom Cold & Flu |
| 58552-137-04 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-b8e6-a426-e053-dadaa90af4c2 | Giltuss Children's Multi-Symptom Cold & Flu |
| 58552-137-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b8e6-a426-e053-dadaa90af4c2 | Giltuss Children's Multi-Symptom Cold & Flu |
| 58552-137-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b8e6-a426-e053-dadaa90af4c2 | Giltuss Children's Multi-Symptom Cold & Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58552-137-04 | Giltuss Childrens MultiSymptom Cold and Flu | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 58552-137-04 | Giltuss Childrens MultiSymptom Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58552-137-04 | ML - Milliliter | 58552-137 | b46426ad-5928-4f39-afc4-b968ee095796 | 1 | 2019-05-02 |
Products#
Every source-derived product name is available through these pages.
- Giltuss Childrens MultiSymptom Cold and Flu
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
- POLYETHYLENE GLYCOL, UNSPECIFIED
- ANHYDROUS CITRIC ACID
- PROPYLPARABEN
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SUCRALOSE
- EDETATE DISODIUM
- EDETIC ACID
- METHYLPARABEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58552-137 | 58552-137-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-10-24 | full-release | 2026-06-01 00:29:54 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | 58552-137-04 58552-137 58552013704 40b8865e-4141-75bb-e063-6394a90aafba 852c8cd6-271f-0fa8-e053-2991aa0ab179 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
