Package Label

SPL v4
SPL
SPL Set ID 995bd7d9-2aef-3792-e053-2a95a90a746d
Route
ORAL
Published
Effective Date 2022-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.


Medication Information

Warnings and Precautions

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

Indications and Usage

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Dosage and Administration

Directions : Ages 12 and up, take 6 drops or pellets by mouth (ages 4 to 11, give 3 drops or pellets) one to four times daily or as directed by a health professional. Under age 4, consult a health professional. Under age 2, crush/dissolve pellets in purified water.

Description

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Section 51945-4

package label

Section 53413-1

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

Section 53414-9

If pregnant or breast-feeding , ask a doctor before use.

Section 55105-1

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Section 55106-9

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium maj. 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig. 15x, Spongia 15x, Tussilago far. 15x, Verbascum 15x, Influenzinum 30x.


Structured Label Content

Indications and Usage (34067-9)

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Dosage and Administration (34068-7)

Directions : Ages 12 and up, take 6 drops or pellets by mouth (ages 4 to 11, give 3 drops or pellets) one to four times daily or as directed by a health professional. Under age 4, consult a health professional. Under age 2, crush/dissolve pellets in purified water.

Warnings and Precautions (34071-1)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Section 51945-4 (51945-4)

package label

Section 53413-1 (53413-1)

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

Section 53414-9 (53414-9)

If pregnant or breast-feeding , ask a doctor before use.

Section 55105-1 (55105-1)

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Section 55106-9 (55106-9)

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium maj. 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig. 15x, Spongia 15x, Tussilago far. 15x, Verbascum 15x, Influenzinum 30x.


Raw Label Data

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